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Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg

NCT05160090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Bupropion HCl MR tablets 300mg

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.

Sponsors & Collaborators

  • Alembic Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Clinical Investigator

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-18
Primary Completion
2020-02-05
Completion
2020-02-05

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160090 on ClinicalTrials.gov