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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 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.

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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

Conditions Studied

Depression

Interventions

  • DRUG generic bupropion

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2014-04
Est. Completion 2016-11
Phase Phase 4

Sponsor

University of Michigan

1,327 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02078180

The ClinicalTrials.gov registry entry for NCT02078180 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.