DepressionPhase 4NCT02078180

Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns

A Phase 4 study testing generic bupropion in people with Depression, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: generic bupropion
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Nov 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109-2700

Other trials in United States

About this study

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: Depression
Being tested: generic bupropion
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

generic bupropionDrug
Also called Wellbutrin
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.

Study groups in NCT02078180
Study group	Role	What they receive
generic bupropion IR75	Active comparator	One oral dose of generic bupropion IR75 Receives: Drug: generic bupropion
generic bupropion IR100	Active comparator	One oral dose of generic bupropion IR100 Receives: Drug: generic bupropion
generic bupropion SR100	Active comparator	One oral dose of generic bupropion SR100 Receives: Drug: generic bupropion
generic bupropion SR150	Active comparator	One oral dose of generic bupropion SR150 Receives: Drug: generic bupropion
generic bupropion XL150	Active comparator	One oral dose of generic bupropion XL150 Receives: Drug: generic bupropion
generic bupropion XL300	Active comparator	One oral dose of generic bupropion XL300 Receives: Drug: generic bupropion

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage
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).
Measured: 4 days

Secondary outcomes (1)

Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage
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 maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.
Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Nov 2016

First posted5 Mar 2014 (estimated)
Study startApr 2014
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02078180
Sponsor's protocol ID: HHSF223201310164C
Other IDs: HUM00081894
Status last verified: Sep 2017
First submitted: 28 Feb 2014
Last updated: 6 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns
ClinicalTrials.gov ID: NCT02078180
Acronym / sponsor ID: HHSF223201310164C
Conditions: Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Apr 2014
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 5 Mar 2014 (estimated)
Results: Posted 6 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and pharmacokinetics of bupropion

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
generic bupropion IR75	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion IR75
generic bupropion IR100	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion IR100
generic bupropion SR100	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion SR100
generic bupropion SR150	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion SR150
generic bupropion XL150	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion XL150
generic bupropion XL300	Active comparator	Drug: generic bupropionOne oral dose of generic bupropion XL300

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
generic bupropionAlso: WellbutrinWe 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.	Drug	generic bupropion IR100, generic bupropion IR75, generic bupropion SR100, generic bupropion SR150, generic bupropion XL150, generic bupropion XL300

Primary outcome

Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage
Time frame: 4 days
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).

1 secondary outcome

Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage
Time frame: 4 days

Results and safety

Results posted to the registry on 6 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IR75, IR200, SR100, SR150, XL150, XL300	34	29

Primary outcome: Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage

Time frame: 4 days. Mean (Standard Deviation). Unit: h*nanogram/milliliter

Measure	Generic Bupropion IR75 n = 30	Generic Bupropion IR100 n = 31	Generic Bupropion SR100 n = 30	Generic Bupropion SR150 n = 32	Generic Bupropion XL150 n = 30	Generic Bupropion XL300 n = 30
Value	469 (177)	667 (418)	706 (304)	1002 (516)	740 (449)	1356 (637)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300	0 of 34 (0%)	10 of 34 (29.4%)	0 of 34

Limitations and caveats (from the sponsor): The small study sample size may have masked the contribution of pharmacogenetics to bupropion metabolism.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duxin Sun, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing generic bupropion in people with Depression, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage (time frame: 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.