xml: <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/NCT06013163</url>
    </required_header>
    <id_info>
      <org_study_id>EP-004</org_study_id>
      <secondary_id>2023-505671-74-00</secondary_id>
      <nct_id>NCT06013163</nct_id>
    </id_info>
    <brief_title>A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers</brief_title>
    <official_title>Control Of BioEquivalence With Xenical (COBEX): A Phase I, Randomised, Active-control Study to Evaluate EMP22 Pharmacodynamics and EMP16 Pharmacokinetics Versus Xenical® in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Empros Pharma AB</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CTC Clinical Trial Consultants AB</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Empros Pharma AB</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims&#xD;
        to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at&#xD;
        steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but&#xD;
        lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs.&#xD;
        Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will&#xD;
        have an open-label, fixed-sequence design. Healthy volunteers will be recruited to the trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 35 participants are planned to be screened to achieve 20 randomised&#xD;
        participants and at least 16 evaluable participants in Part I.&#xD;
  &#xD;
        All participants who complete Part I will continue in Part II.&#xD;
  &#xD;
        Each participant is expected to participate in the trial for approximately 9 to 13 weeks&#xD;
        (depending on the length of each wash-out period), including a 28-day screening period.&#xD;
  &#xD;
        Part I: Participants will self-administer EMP22 for 9 days and Xenical® for 9 days (TID&#xD;
        dosing) at home. EMP22 and Xenical® should be taken halfway through each of the 3 main meals&#xD;
        during the day (breakfast, lunch, dinner) with approximately 50 to 200 mL water.&#xD;
  &#xD;
        EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In&#xD;
        order to maintain the blind for the participants, the IMP will be administered as follows:&#xD;
  &#xD;
          -  EMP22 60 mg orlistat, 2 capsules TID.&#xD;
  &#xD;
          -  Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID.&#xD;
  &#xD;
        Part II: Following an overnight fast of at least 8 hours and a light standardised breakfast&#xD;
        upon admission (approximately 2 hours prior to dose), EMP16 will be taken halfway through a&#xD;
        regular standardised breakfast (5 minutes after the start of the meal, which is expected to&#xD;
        be finished in 10 minutes) with approximately 50 to 200 mL water. After a 4-14 day washout,&#xD;
        the same procedure will be repeated using Xenical® .&#xD;
  &#xD;
        The participants will receive a single dose dose of EMP16 (2 capsules, each of 60 mg) and a&#xD;
        single dose of Xenical® (1 capsule, 120 mg).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>
      <intervention_model_description>In Part I (single-blind), EMP22 (120 mg orlistat) and orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for two 9-day treatment periods in a cross-over manner.&#xD;
  In Part II (open-label), single doses of EMP16 (120 mg orlistat/40 mg acarbose) and Xenical® (120 mg orlistat) will be taken together with breakfast on 2 separate days.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Part I: EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind, the IMP will be administered as follows:&#xD;
  EMP22 60 mg orlistat, 2 capsules TID.&#xD;
  Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID. EMP22, Xenical® and placebo will be identical in appearance.&#xD;
  Part II will be open-label, i.e., the Investigator, trial staff and trial participants will know which treatment, EMP16 or Xenical®, that is given at each visit.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The percent of faecal fat</measure>
      <time_frame>Day -2 , Day -1 , and between the morning of Day 9 and Day 10.</time_frame>
      <description>The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax - to explore the PK properties of EMP16</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>Cmax for orlistat and acarbose</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax - to explore the PK properties of EMP16</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>Tmax for orlistat and acarbose</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-t - to explore the PK properties of EMP16</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>AUC0-t for orlistat and acarbose</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>Cmax for orlistat</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>Tmax for orlistat</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-t - to compare the bioavailability of orlistat in EMP16 and Xenical®</measure>
      <time_frame>12 hour for each day of treatment</time_frame>
      <description>AUC0-t for orlistat</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Overweight or Obesity</condition>
    <arm_group>
      <arm_group_label>Xenical - EMP22 part 1 crossover blinded</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EMP22 - Xenical part 1 crossover blinded</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EMP16 - Xenical part 2 sequential open label</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Xenical® vs EMP 22</intervention_name>
      <description>Each participant will first use Xenical® TID for 9 days and then EMP22TID for 9 days (in total 27 doses of each drug).</description>
      <arm_group_label>Xenical - EMP22 part 1 crossover blinded</arm_group_label>
      <other_name>Part I</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EMP 22 vs Xenical®</intervention_name>
      <description>Each participant will first use EMP22 TID for 9 days and then Xenical® TID for 9 days (in total 27 doses of each drug).</description>
      <arm_group_label>EMP22 - Xenical part 1 crossover blinded</arm_group_label>
      <other_name>Part I</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EMP 16 vs Xenical®</intervention_name>
      <description>Each participant will receive a single dose of EMP16 and then a single dose of Xenical®.</description>
      <arm_group_label>EMP16 - Xenical part 2 sequential open label</arm_group_label>
      <other_name>Part II</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Willing and able to give written informed consent for participation in the trial.&#xD;
  &#xD;
            2. Healthy male or female aged 20 to 55 years inclusive.&#xD;
  &#xD;
            3. Participants with a BMI between 20 and 27 kg/m² or participants with a BMI &gt;27 kg/m2&#xD;
               and normal body fat composition (10 to 25% for men and 20 to 30% for women measured&#xD;
               using a bioimpedance scale) at screening.&#xD;
  &#xD;
            4. Weight stable (&lt;5% self-reported change during the previous 3 months preceding&#xD;
               screening).&#xD;
  &#xD;
            5. Participants with a self-perceived normality in defecation habits, normally with a&#xD;
               stool frequency of at least once daily.&#xD;
  &#xD;
            6. Medically healthy participant without abnormal clinically significant medical history,&#xD;
               physical findings, vital signs, electrocardiogram (ECG) and laboratory values at the&#xD;
               time of the screening visit, as judged by the Investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of any clinically significant disease or disorder which, in the opinion of the&#xD;
               Investigator, may either put the participant at risk because of participation in the&#xD;
               trial, or influence the results or the participant's ability to participate in the&#xD;
               trial including but not limited to:&#xD;
  &#xD;
                 -  GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel&#xD;
                    syndrome (IBS).&#xD;
  &#xD;
                 -  Cholestasis.&#xD;
  &#xD;
                 -  Previous GI surgery that might influence GI function significantly, such as&#xD;
                    previous bariatric surgery, and previous gallbladder surgery as judged by the&#xD;
                    investigator.&#xD;
  &#xD;
                 -  Vitamin B12 deficiency or other signs of achlorhydria.&#xD;
  &#xD;
                 -  Chronical malabsorption syndrome.&#xD;
  &#xD;
                 -  History of severe allergic, cardiac or hepatic disease.&#xD;
  &#xD;
            2. Any clinically significant illness, medical/surgical procedure or trauma within 4&#xD;
               weeks of the first administration of IMP.&#xD;
  &#xD;
            3. Malignancy within the past 5 years, with the exception of in situ removal of basal&#xD;
               cell carcinoma.&#xD;
  &#xD;
            4. Any planned major surgery within the duration of the trial.&#xD;
  &#xD;
            5. Participants who are pregnant, currently breastfeeding, or intend to become pregnant&#xD;
               during the course of the trial.&#xD;
  &#xD;
            6. Any positive result at the screening visit for serum hepatitis B surface antigen,&#xD;
               hepatitis C antibodies and/or human immunodeficiency virus (HIV).&#xD;
  &#xD;
            7. Prolonged QTcF (&gt;450 ms), cardiac arrhythmias or any clinically significant&#xD;
               abnormalities in the resting ECG at the screening visit, as judged by the&#xD;
               Investigator.&#xD;
  &#xD;
            8. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as&#xD;
               judged by the Investigator, or history of hypersensitivity to drugs with a similar&#xD;
               chemical structure or class as orlistat or acarbose.&#xD;
  &#xD;
            9. Regular use of any prescribed or non-prescribed medications (including, but not&#xD;
               limited to, antacids, analgesics, herbal remedies, vitamins and minerals) within 2&#xD;
               weeks prior to the first administration of IMP except as outlined in Section 9.6.2.3.&#xD;
  &#xD;
           10. Administration of another new chemical entity (defined as a compound which has not&#xD;
               been approved for marketing) or has participated in any other clinical trial that&#xD;
               included drug treatment within 3 months of the first administration of IMP in this&#xD;
               trial. Subjects consented and screened but not dosed in previous studies are not&#xD;
               excluded.&#xD;
  &#xD;
           11. Current smokers or users of nicotine products. Irregular use of nicotine (e.g.,&#xD;
               smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before the&#xD;
               screening visit.&#xD;
  &#xD;
           12. Positive screening result for drugs of abuse or alcohol at the screening visit.&#xD;
  &#xD;
           13. History of alcohol abuse or excessive intake of alcohol, as judged by the&#xD;
               Investigator.&#xD;
  &#xD;
           14. Presence or history of drug abuse, as judged by the Investigator.&#xD;
  &#xD;
           15. History of, or current use of anabolic steroids, as judged by the Investigator.&#xD;
  &#xD;
           16. Excessive caffeine consumption defined by a daily intake of &gt; 5 cups (1 cup =&#xD;
               approximately 240 mL) of caffeine containing beverages, as judged by the Investigator.&#xD;
  &#xD;
           17. Plasma donation within 1 month of screening or blood donation (or corresponding blood&#xD;
               loss) during the last 3 months prior to screening.&#xD;
  &#xD;
           18. The Investigator considers the participant unlikely to comply with trial procedures,&#xD;
               restrictions and requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ulf Holmbäck</last_name>
      <role>Study Chair</role>
      <affiliation>Empros Pharma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ulf Holmbäck, PhD</last_name>
      <phone>+4670 173 00 41</phone>
      <email>ulf.holmback@emprospharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ulf Holmbäck</last_name>
      <phone>+4670 173 00 41</phone>
      <email>ulf.holmback@emprospharma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CTC Clinical Trial Consultanta AB</name>
        <address>
          <city>Uppsala</city>
          <zip>752 37</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Helena Litorp, MD, PhD</last_name>
        <phone>+46 (0)72 225 00 75</phone>
        <email>helena.litorp@ctc-ab.se</email>
      </contact>
      <investigator>
        <last_name>Helena Litorp, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Overweight, Obesity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Orlistat</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013163
  org study id: EP-004
  secondary id: 2023-505671-74-00
  nct id: NCT06013163
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims
        to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at
        steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but
        lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs.
        Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will
        have an open-label, fixed-sequence design. Healthy volunteers will be recruited to the trial.
  Approximately 35 participants are planned to be screened to achieve 20 randomised
        participants and at least 16 evaluable participants in Part I.
  
        All participants who complete Part I will continue in Part II.
  
        Each participant is expected to participate in the trial for approximately 9 to 13 weeks
        (depending on the length of each wash-out period), including a 28-day screening period.
  
        Part I: Participants will self-administer EMP22 for 9 days and Xenical® for 9 days (TID
        dosing) at home. EMP22 and Xenical® should be taken halfway through each of the 3 main meals
        during the day (breakfast, lunch, dinner) with approximately 50 to 200 mL water.
  
        EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In
        order to maintain the blind for the participants, the IMP will be administered as follows:
  
          -  EMP22 60 mg orlistat, 2 capsules TID.
  
          -  Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID.
  
        Part II: Following an overnight fast of at least 8 hours and a light standardised breakfast
        upon admission (approximately 2 hours prior to dose), EMP16 will be taken halfway through a
        regular standardised breakfast (5 minutes after the start of the meal, which is expected to
        be finished in 10 minutes) with approximately 50 to 200 mL water. After a 4-14 day washout,
        the same procedure will be repeated using Xenical® .
  
        The participants will receive a single dose dose of EMP16 (2 capsules, each of 60 mg) and a
        single dose of Xenical® (1 capsule, 120 mg).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: In Part I (single-blind), EMP22 (120 mg orlistat) and orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for two 9-day treatment periods in a cross-over manner.
  In Part II (open-label), single doses of EMP16 (120 mg orlistat/40 mg acarbose) and Xenical® (120 mg orlistat) will be taken together with breakfast on 2 separate days.
  primary purpose: Basic Science
  masking: Single (Participant)
  masking description: Part I: EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind, the IMP will be administered as follows:
  EMP22 60 mg orlistat, 2 capsules TID.
  Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID. EMP22, Xenical® and placebo will be identical in appearance.
  Part II will be open-label, i.e., the Investigator, trial staff and trial participants will know which treatment, EMP16 or Xenical®, that is given at each visit.
  measure: The percent of faecal fat
  time frame: Day -2 , Day -1 , and between the morning of Day 9 and Day 10.
  description: The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.
  measure: Cmax - to explore the PK properties of EMP16
  time frame: 12 hour for each day of treatment
  description: Cmax for orlistat and acarbose
  measure: Tmax - to explore the PK properties of EMP16
  time frame: 12 hour for each day of treatment
  description: Tmax for orlistat and acarbose
  measure: AUC0-t - to explore the PK properties of EMP16
  time frame: 12 hour for each day of treatment
  description: AUC0-t for orlistat and acarbose
  measure: Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
  time frame: 12 hour for each day of treatment
  description: Cmax for orlistat
  measure: Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
  time frame: 12 hour for each day of treatment
  description: Tmax for orlistat
  measure: AUC0-t - to compare the bioavailability of orlistat in EMP16 and Xenical®
  time frame: 12 hour for each day of treatment
  description: AUC0-t for orlistat
  arm group label: Xenical - EMP22 part 1 crossover blinded
  arm group type: Active Comparator
  description: After a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
  arm group label: EMP22 - Xenical part 1 crossover blinded
  arm group type: Active Comparator
  description: After a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
  arm group label: EMP16 - Xenical part 2 sequential open label
  arm group type: Active Comparator
  description: Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.
  intervention type: Drug
  intervention name: Xenical® vs EMP 22
  description: Each participant will first use Xenical® TID for 9 days and then EMP22TID for 9 days (in total 27 doses of each drug).
  arm group label: Xenical - EMP22 part 1 crossover blinded
  other name: Part I
  intervention type: Drug
  intervention name: EMP 22 vs Xenical®
  description: Each participant will first use EMP22 TID for 9 days and then Xenical® TID for 9 days (in total 27 doses of each drug).
  arm group label: EMP22 - Xenical part 1 crossover blinded
  other name: Part I
  intervention type: Drug
  intervention name: EMP 16 vs Xenical®
  description: Each participant will receive a single dose of EMP16 and then a single dose of Xenical®.
  arm group label: EMP16 - Xenical part 2 sequential open label
  other name: Part II
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ulf Holmbäck
  role: Study Chair
  affiliation: Empros Pharma
  last name: Ulf Holmbäck, PhD
  phone: +4670 173 00 41
  email: ulf.holmback@emprospharma.com
  last name: Ulf Holmbäck
  phone: +4670 173 00 41
  email: ulf.holmback@emprospharma.com
  facility: 
  contact: 
  investigator: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Overweight
  mesh term: Orlistat