Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Bupropion HCl MR tablets 300mg
Intervention type(s): Drug
Intervention description(s): In each study period, a single 300 mg dose of Bupropion will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.
Other intervention name(s): Reference-Elontril (Bupropion HCl) MR tablets 300mg
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
Masking: None (Open Label)
Primary purpose: Other