<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240160</url>
  </required_header>
  <id_info>
    <org_study_id>GWCP10116</org_study_id>
    <secondary_id>2013-004459-19</secondary_id>
    <nct_id>NCT02240160</nct_id>
  </id_info>
  <brief_title>A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects</brief_title>
  <official_title>A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of&#xD;
      Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol&#xD;
      (CBD)) by comparing the PK profile of Sativex in healthy subjects.&#xD;
&#xD;
      The primary clinical hypothesis is that there will be an effect of oral pH on the PK of&#xD;
      Sativex when administered as a single oromucosal dose (four sprays).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, randomised, open-label, three-way crossover study to assess the effects of&#xD;
      oral pH on the PK of Sativex. Subjects will receive each of the following treatments in a&#xD;
      random order across three residential treatment visits:&#xD;
&#xD;
        -  Treatment A (acidic oral pH): Sativex (four sprays) after pre-treatment with Coca-Cola;&#xD;
&#xD;
        -  Treatment B (neutral oral pH): Sativex (four sprays) after pre-treatment with tap water;&#xD;
&#xD;
        -  Treatment C (alkaline oral pH): Sativex (four sprays) after pre-treatment with an oral&#xD;
           suspension of magnesium hydroxide (milk of magnesia).&#xD;
&#xD;
      The target pH for each treatment will be determined from the results of a pilot study.&#xD;
&#xD;
      Each dose administration will be separated by at least seven days. Study subjects will&#xD;
      participate in a total of five study visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameters of THC: Cmax, AUC(0-t), and AUC(0-∞)</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean highest observed plasma concentration of the measured concentration-time profile (Cmax), area under the concentration-time curve from administration to the last sampling point (AUC(0-t)), and area under the concentration-time curve extrapolated to infinity (AUC(0-∞)) of THC are presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters of CBD: Cmax, AUC(0-t), and AUC(0-∞)</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean Cmax, AUC(0-t), and AUC(0-∞) of CBD are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 11-hydroxy-CBD (11-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean Cmax, AUC(0-t), and AUC(0-∞) of 11-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 7-hydroxy-CBD (7-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean Cmax, AUC(0-t), and AUC(0-∞) of 7-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 6-hydroxy-CBD (6-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean Cmax, AUC(0-t), and AUC(0-∞) of 6-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of THC: t½ and Tmax</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean terminal elimination half-life (t½) and time to maximum plasma concentration (Tmax) of THC are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 11-OH-CBD: t½ and Tmax</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean t½ and Tmax of 11-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of CBD: t½ and Tmax</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean t½ and Tmax of CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 7-OH-CBD: t½ and Tmax</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean t½ and Tmax of 7-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of 6-OH-CBD: t½ and Tmax</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean t½ and Tmax of 6-OH-CBD are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance (CL/F) of THC and CBD from plasma</measure>
    <time_frame>0-24 hours post-dose</time_frame>
    <description>Mean total body clearance of THC and CBD from plasma is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse events as measure of subject safety</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to the follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with a clinically significant change in 12-lead electrocardiogram (ECG) results, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with clinically significant changes in serum biochemistry, haematology and urinalysis, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with a change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) indicative of an adverse event, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with a clinically significant change in body temperature, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with a change in body temperature indicative of an adverse event, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects with a clinically significant change in body weight, relative to pre-treatment baseline</measure>
    <time_frame>From screening to follow-up, an expected average of 35 days</time_frame>
    <description>The number of subjects with a change in body weight indicative of an adverse event, relative to the pre-treatment baseline, is presented.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Sativex: acidic oral pH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with Coca-Cola (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sativex: neutral oral pH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with tap water (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sativex: alkaline oral pH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with milk of magnesia (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sativex</intervention_name>
    <description>Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.</description>
    <arm_group_label>Sativex: acidic oral pH</arm_group_label>
    <arm_group_label>Sativex: alkaline oral pH</arm_group_label>
    <arm_group_label>Sativex: neutral oral pH</arm_group_label>
    <other_name>Nabiximols</other_name>
    <other_name>THC/CBD spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is willing and able to give informed consent for participation in the study;&#xD;
&#xD;
          -  Male and/or female subjects aged 18 to 50 years, inclusive;&#xD;
&#xD;
          -  Subject must weigh at least 50.0 kg and have a body mass index (BMI) between 19.0 and&#xD;
             35.0 kg/m2, inclusive;&#xD;
&#xD;
          -  Subject must be a non-smoker for at least three months prior to screening and must be&#xD;
             willing to abstain from smoking during the study;&#xD;
&#xD;
          -  Subject must be in good health as determined by the investigator from medical history,&#xD;
             physical and oral examination findings, 12-lead standard ECG findings and clinical&#xD;
             laboratory test results (laboratory results outside of the reference range must be&#xD;
             documented as acceptable by both the investigator and sponsor);&#xD;
&#xD;
          -  Subject is able (in the investigator's opinion) and willing to comply with all study&#xD;
             requirements;&#xD;
&#xD;
          -  Subject is willing to allow his or her primary care practitioner and consultant, if&#xD;
             appropriate, to be notified of participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any prescription medications or herbal supplements within 2 weeks prior to Day&#xD;
             1 of the first treatment visit or any over the counter medications or supplements&#xD;
             within 72 hours prior to first study medication administration;&#xD;
&#xD;
          -  Subject has oral issues/condition likely, in the opinion of the investigator, to&#xD;
             affect the assessment of the oromucosal absorption of Sativex;&#xD;
&#xD;
          -  Subject is physically dependent on alcohol, has a history of drug or alcohol abuse&#xD;
             within the 12 months prior to dose administration or evidence of such abuse as&#xD;
             indicated by the laboratory assays conducted during the screening or baseline&#xD;
             evaluations;&#xD;
&#xD;
          -  Subject has a positive result for the presence of hepatitis B surface antigen (HBsAg),&#xD;
             hepatitis C virus antibodies (HCAb) or human immunodeficiency virus (HIV) antibodies;&#xD;
&#xD;
          -  Subject is currently using or has used cannabis, cannabinoid-based medications (e.g.&#xD;
             Marinol®, Nabilone®, Cannador®) or Acomplia (rimonabant) or taranabant within 30 days&#xD;
             of study entry (first treatment visit) and is unwilling to abstain for the duration of&#xD;
             the study;&#xD;
&#xD;
          -  Subject consumes more than five caffeinated beverages per day (e.g., five cups of tea&#xD;
             or coffee or cans of cola) or is unwilling to abstain from consumption of&#xD;
             caffeine-containing food and beverages throughout the study period;&#xD;
&#xD;
          -  Subject has any known or suspected history or family history of schizophrenia, or&#xD;
             other psychotic illness, history of severe personality disorder or other significant&#xD;
             psychiatric disorder;&#xD;
&#xD;
          -  Subject has any history of epilepsy as evidenced by one or more seizures in the last&#xD;
             12 months;&#xD;
&#xD;
          -  Subject has any known or suspected hypersensitivity to cannabinoids or any of the&#xD;
             excipients of the investigational medicinal product (IMP), Coca-Cola or antacid&#xD;
             medications;&#xD;
&#xD;
          -  Subject who has received an IMP within the 12 weeks prior to the screening visit, or&#xD;
             who has received the last dose of an IMP greater than three months ago but is on&#xD;
             extended follow-up;&#xD;
&#xD;
          -  Subject with any other significant disease or disorder which, in the opinion of the&#xD;
             investigator, may either put the subject at risk because of participation in the&#xD;
             study, may influence the result of the study or the subject's ability to participate&#xD;
             in the study;&#xD;
&#xD;
          -  Following a physical examination, the subject has any abnormalities that, in the&#xD;
             opinion of the investigator would prevent the subject from safe participation in the&#xD;
             study;&#xD;
&#xD;
          -  Travel outside the country of residence planned during the study;&#xD;
&#xD;
          -  Subjects who are vegans or have medical dietary restrictions.&#xD;
&#xD;
          -  Subject has a positive urine drug (including THC), cotinine or alcohol result at&#xD;
             screening or at Day -1 of first treatment visit; or positive urine drug (excluding&#xD;
             THC), cotinine or alcohol result at Day -1 of subsequent treatment visits;&#xD;
&#xD;
          -  Female subjects of child bearing potential and male subjects whose partner is of child&#xD;
             bearing potential, unless willing to ensure that they or their partner use two&#xD;
             effective forms of contraception e.g, oral contraception, double barrier or&#xD;
             intra-uterine device (IUD), during the study and for three months thereafter (however&#xD;
             a male condom should not be used in conjunction with a female condom);&#xD;
&#xD;
          -  Female subject who is pregnant, lactating or planning pregnancy during the course of&#xD;
             the study and for three months thereafter;&#xD;
&#xD;
          -  Subjects who have donated or lost more than 450 mL of blood in the 60 days prior to&#xD;
             screening or are unwilling to abstain from donation of blood during the study;&#xD;
&#xD;
          -  Subject has previously been randomised into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Ritter, DPhil, FRCP, FMedSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd, 6 Newcomen Street, London SE1 1YR, United Kingdom</affiliation>
  </overall_official>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sativex</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Oral pH</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nabiximols</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240160
org study id: GWCP10116
secondary id: 2013-004459-19
nct id: NCT02240160
lead sponsor: 
has dmc: No
To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of
      Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol
      (CBD)) by comparing the PK profile of Sativex in healthy subjects.

      The primary clinical hypothesis is that there will be an effect of oral pH on the PK of
      Sativex when administered as a single oromucosal dose (four sprays).
This is a Phase I, randomised, open-label, three-way crossover study to assess the effects of
      oral pH on the PK of Sativex. Subjects will receive each of the following treatments in a
      random order across three residential treatment visits:

        -  Treatment A (acidic oral pH): Sativex (four sprays) after pre-treatment with Coca-Cola;

        -  Treatment B (neutral oral pH): Sativex (four sprays) after pre-treatment with tap water;

        -  Treatment C (alkaline oral pH): Sativex (four sprays) after pre-treatment with an oral
           suspension of magnesium hydroxide (milk of magnesia).

      The target pH for each treatment will be determined from the results of a pilot study.

      Each dose administration will be separated by at least seven days. Study subjects will
      participate in a total of five study visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetic parameters of THC: Cmax, AUC(0-t), and AUC(0-∞)
time frame: 0-24 hours post-dose
description: Mean highest observed plasma concentration of the measured concentration-time profile (Cmax), area under the concentration-time curve from administration to the last sampling point (AUC(0-t)), and area under the concentration-time curve extrapolated to infinity (AUC(0-∞)) of THC are presented.
measure: Pharmacokinetic parameters of CBD: Cmax, AUC(0-t), and AUC(0-∞)
time frame: 0-24 hours post-dose
description: Mean Cmax, AUC(0-t), and AUC(0-∞) of CBD are presented.
measure: Pharmacokinetic parameters of 11-hydroxy-CBD (11-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)
time frame: 0-24 hours post-dose
description: Mean Cmax, AUC(0-t), and AUC(0-∞) of 11-OH-CBD are presented.
measure: Pharmacokinetic parameters of 7-hydroxy-CBD (7-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)
time frame: 0-24 hours post-dose
description: Mean Cmax, AUC(0-t), and AUC(0-∞) of 7-OH-CBD are presented.
measure: Pharmacokinetic parameters of 6-hydroxy-CBD (6-OH-CBD): Cmax, AUC(0-t), and AUC(0-∞)
time frame: 0-24 hours post-dose
description: Mean Cmax, AUC(0-t), and AUC(0-∞) of 6-OH-CBD are presented.
measure: Pharmacokinetic parameters of THC: t½ and Tmax
time frame: 0-24 hours post-dose
description: Mean terminal elimination half-life (t½) and time to maximum plasma concentration (Tmax) of THC are presented.
measure: Pharmacokinetic parameters of 11-OH-CBD: t½ and Tmax
time frame: 0-24 hours post-dose
description: Mean t½ and Tmax of 11-OH-CBD are presented.
measure: Pharmacokinetic parameters of CBD: t½ and Tmax
time frame: 0-24 hours post-dose
description: Mean t½ and Tmax of CBD are presented.
measure: Pharmacokinetic parameters of 7-OH-CBD: t½ and Tmax
time frame: 0-24 hours post-dose
description: Mean t½ and Tmax of 7-OH-CBD are presented.
measure: Pharmacokinetic parameters of 6-OH-CBD: t½ and Tmax
time frame: 0-24 hours post-dose
description: Mean t½ and Tmax of 6-OH-CBD are presented.
measure: Total body clearance (CL/F) of THC and CBD from plasma
time frame: 0-24 hours post-dose
description: Mean total body clearance of THC and CBD from plasma is presented.
measure: The incidence of adverse events as measure of subject safety
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to the follow-up visit.
measure: The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
measure: The number of subjects with a clinically significant change in 12-lead electrocardiogram (ECG) results, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
measure: The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with clinically significant changes in serum biochemistry, haematology and urinalysis, relative to the pre-treatment baseline, is presented.
measure: The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with a change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) indicative of an adverse event, relative to the pre-treatment baseline, is presented.
measure: The number of subjects with a clinically significant change in body temperature, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with a change in body temperature indicative of an adverse event, relative to the pre-treatment baseline, is presented.
measure: The number of subjects with a clinically significant change in body weight, relative to pre-treatment baseline
time frame: From screening to follow-up, an expected average of 35 days
description: The number of subjects with a change in body weight indicative of an adverse event, relative to the pre-treatment baseline, is presented.
arm group label: Sativex: acidic oral pH
arm group type: Experimental
description: Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with Coca-Cola (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).
arm group label: Sativex: neutral oral pH
arm group type: Experimental
description: Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with tap water (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).
arm group label: Sativex: alkaline oral pH
arm group type: Experimental
description: Four sprays of Sativex taken within two minutes of pH measurement immediately following oral pre-treatment with milk of magnesia (30 mL held in the mouth for 45-60 seconds then spat out, repeated three times).
intervention type: Drug
intervention name: Sativex
description: Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.
arm group label: Sativex: acidic oral pH
arm group label: Sativex: alkaline oral pH
arm group label: Sativex: neutral oral pH
other name: Nabiximols
other name: THC/CBD spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James Ritter, DPhil, FRCP, FMedSci
role: Principal Investigator
affiliation: Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd, 6 Newcomen Street, London SE1 1YR, United Kingdom
responsible party type: Sponsor
mesh term: Nabiximols