Name of Clinical Study 2 the format provided below, please provide details of each clinical trial conducted to establish the efficacy of the subsequent entry non-biologic complex drug relative to the reference product. Add additional tables and sections as needed. a) Study Characteristics Provide a brief description of the study (one paragraph). Complete the table below with all of the requested information. Characteristics Details for [Provide study name] e.g., Pivotal pharmacokinetic study, pivotal efficacy and safety study Objective Blinding Blinding of investigators and/or subjects (e.g., double-blind, open-label) Study period State the beginning and end dates of the study (YYYY-MM to YYYY-MM) Study Study centres List the number of centres and the countries involved Design Design e.g., equivalence or non-inferiority Randomized (N) # Inclusion criteria Major criteria only Exclusion criteria List only criteria Population Intervention Drug, dose, route of administration, frequency of administration Comparator(s) Drug, dose, route of administration, and frequency of administration, for each comparator Run-in Specify the duration Treatment Specify the duration Follow-up Specify the duration Duration Define the end Primary End End Points Publications Provide references for all publications related to this study. Provide the clinicaltrials.gov identification code (e.g., NCTXXXXXXXX). Notes Intervention and Comparators Briefly describe the interventions employed in the trial, including dose, route and frequency of administration, duration, etc. Please clearly if a non-Canadian reference product was used in the If the trial is blinded, indicate the use of matched placebos, double-dummy controls, etc. Describe any concomitant medications required or permitted during the study. Outcomes Describe the key efficacy and safety outcomes for the study (definitions and measurement).
Name of Clinical Study 2 the format provided below, please provide details of each clinical trial conducted to establish the efficacy of the subsequent entry non-biologic complex drug relative to the reference product. Add additional tables and sections as needed. a) Study Characteristics Provide a brief description of the study (one paragraph). Complete the table below with all of the requested information. Characteristics Details for [Provide study name] Study Design Objective e.g., Pivotal pharmacokinetic study, pivotal efficacy and safety study Blinding Blinding of investigators and/or subjects (e.g., double-blind, open-label) Study period State the beginning and end dates of the study (YYYY-MM to YYYY-MM) Study centres List the number of centres and the countries involved Design e.g., equivalence or non-inferiority Population Randomized (N) # Inclusion criteria Major criteria only Exclusion criteria List only criteria Intervention Drug, dose, route of administration, frequency of administration Comparator(s) Drug, dose, route of administration, and frequency of administration, for each comparator Duration Run-in Specify the duration Treatment Specify the duration Follow-up Specify the duration Primary End Define the end End Points Notes Publications Provide references for all publications related to this study. Provide the clinicaltrials.gov identification code (e.g., NCTXXXXXXXX). Intervention and Comparators Briefly describe the interventions employed in the trial, including dose, route and frequency of administration, duration, etc. Please clearly if a non-Canadian reference product was used in the If the trial is blinded, indicate the use of matched placebos, double-dummy controls, etc. Describe any concomitant medications required or permitted during the study. Outcomes Describe the key efficacy and safety outcomes for the study (definitions and measurement).
CADTH_NBCD_Template.docx