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Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns

NCT ID: NCT02078180

Last Updated: 2017-10-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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generic bupropion IR75

One oral dose of generic bupropion IR75

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

generic bupropion IR100

One oral dose of generic bupropion IR100

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

generic bupropion SR100

One oral dose of generic bupropion SR100

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

generic bupropion SR150

One oral dose of generic bupropion SR150

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

generic bupropion XL150

One oral dose of generic bupropion XL150

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

generic bupropion XL300

One oral dose of generic bupropion XL300

Group Type ACTIVE_COMPARATOR

generic bupropion

Intervention Type DRUG

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

Interventions

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generic bupropion

We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

Intervention Type DRUG

Other Intervention Names

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Wellbutrin

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers 25 to 55 years old.
* Volunteers have a Body Mass Index (BMI), calculated from the ratio of height and weight, within a range of 18.5 to 35.
* Willing to be medication and supplement free 2 weeks prior to beginning study, and throughout the study. All forms of birth control are okay.

Exclusion Criteria

* Individuals unwilling or unable to comply with the study protocol (e.g. unable to remain medication or supplement free during the study).
* Individuals unwilling or unable to take bupropion or have an allergy to bupropion
* Any medical or surgical conditions which might significantly alter bupropion absorption (e.g., history of malabsorption, liver disease, gastric bypass surgery )
* Individuals with a history of psychiatric or neurological illness, including seizure disorders
* Nicotine dependence
* Alcohol dependence
* Pregnant or nursing women
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Duxin Sun

Professor of Pharmaceutical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duxin Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00081894

Identifier Type: OTHER

Identifier Source: secondary_id

HHSF223201310164C

Identifier Type: -

Identifier Source: org_study_id