Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg
- Registration Number
- NCT05160090
- Lead Sponsor
- Alembic Pharmaceuticals Ltd.
- Brief Summary
The objective of this study is to determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions.
The secondary objective of this study is to evaluate the safety and tolerability of the Test and Reference formulations in healthy subjects.
- Detailed Description
This is a single center, randomized, 2-treatment, 2-period, 2-sequence, crossover, single dose study design, in which 34 healthy adult subjects will receive 1 of the study treatments during each study period.
Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 10 hours prior to drug administration for each study period.
For each study period, subjects will receive a single 300 mg oral dose of bupropion, under fasting conditions and undergo a 96-hour PK sample collection. Subjects are to be discharged from the clinic after the 36-hour postdose PK sample collection, and following medical approval. However, they may be advised to stay at the clinical site for safety reasons, if judged necessary by the physician in charge. Subjects will return to the clinic for blood collections at 48, 72, and 96 hours postdose.
The drug administrations in each period will be separated by at least 14 calendar days.
The duration of the clinical portion of this study (excluding the screening period) is expected to be approximately 19 days. The actual overall study duration may vary.
Tests during study:
An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as before discharge of each period. Neurologic Function Test will be performed at screening, approximately 26 hours after each drug administration \& end of the study.
For female subjects, a serum pregnancy test will be performed before each period of the study \& end of study.
Vital signs will be measured prior to and approximately 2.5, 4, 6, 12, 24, and 36 hours following each drug administration.
Safety assessments will include physical examination, vital signs, clinical laboratory tests, neurologic function tests, and AE monitoring. Additional safety measurements may be performed at the discretion of the investigator for reasons related to subject safety.
The physician in charge will be present at the clinical site for at least the first 6 hours following each drug administration and will remain available at all times throughout the study.
Post study Tests:
Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study.
A complete physical examination (including vital signs) will also be performed.
Bioanalysis: Bupropion \& its metabolites plasma concentrations will be measured by a validated bioanalytical method.
Standards for Bioequivalence:
Statistical inference of bupropion will be based on a bioequivalence approach using the following standards:
The ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and Reference products for the ln-transformed parameters Cmax, AUC0-T, AUC0-∞, should all be within the 80.00 to 125.00% bioequivalence range.
For the metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) , the same criteria will be applied and the results will be presented as supportive evidence of comparable therapeutic outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test- BUPROPION HCl MR TABLETS 300mg Bupropion HCl MR tablets 300mg Single dose of Test- BUPROPION HCl MR TABLETS 300mg Reference-Elontril 300 mg Bupropion HCl MR tablets 300mg Elontril 300 mg (Bupropion HCl MR tablets 300mg)
- Primary Outcome Measures
Name Time Method Cmax Up to 96.00 hours Maximum observed concentration occurring at time Tmax
AUC0-T Up to 96.00 hours Area under the concentration time curve from the time of last dosing to Tlast.
AUC0-∞ Up to 96.00 hours Area under the concentration time curve extrapolated to infinity, calculated as AUCT + ĈLQC/λZ, where ĈLQC is the predicted concentration at time Tlast
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Algorithme Pharma
🇨🇦Mount Royal, Quebec, Canada
Algorithme Pharma Inc.
🇨🇦Mount-Royal, Quebec, Canada