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NCT02078180 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns
A Phase 4 study of Depression, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT02078180: Completed Phase 4 study of Depression, sponsored by University of Michigan.
NCT02078180 is a Phase 4 study of Depression that has completed, run by University of Michigan. The registered enrollment target is 34 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02078180, a Phase 4 study of Depression, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this project are to determine if the bioavailability and release pattern of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER) Office of Generic Drugs improve policy development and review practice in the future for similar products, e.g. extended release oral drug products being metabolized in the gut wall and having multiple strengths. Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy individuals when they ingest different strengths of bupropion (75-300 mg) with variable release profiles (IR vs XL vs SR) in GI tract. Working hypothesis: Variation in release rate and mechanism of bupropion formulations in gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract, which will generate different concentration of bupropion and its metabolites in plasma. Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and pharmacokinetics of bupropion Working hypothesis: The gain of function of CYP2B6 variants (allele \*4 and \*22) in patients will increase the metabolism of bupropion in the GI tract and liver, reduce both local concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when bupropion is released earlier in GI tract
Primary Outcome
Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).
Conditions Studied
Interventions
- DRUG generic bupropion
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
What the finished NCT02078180 record still lists
NCT02078180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 1 intervention - of which generic bupropion is the first listed.
NCT02078180 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02078180 about?
NCT02078180 is a clinical study titled "Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns". The objectives of this project are to determine if the bioavailability and release pattern of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. Findings from this project will...
What is the current status of trial NCT02078180?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2014-04. Estimated completion is 2016-11.
What conditions does trial NCT02078180 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT02078180?
The interventions under investigation include: generic bupropion (DRUG).
Who is sponsoring clinical trial NCT02078180?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02078180 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02078180's enrollment target sits among peer trials
34 546th of 679 higher than 132 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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