HealthyPhase 1NCT00865410
A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions
A Phase 1 study testing Abrika Bupropion 150 mg Extended-Released Tablet and Wellbutrin SR® 150 mg Extended-Release Tablet, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) dose in fasted subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Abrika Bupropion 150 mg Extended-Released Tablet and Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Sep 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is the individual a healthy, normal adult man who volunteers to participate?
- Is he 18-45 years of age, inclusive?
- Is his BMI ≤30?
- Is he considered reliable and capable of understanding his responsibility and role in the study?
- Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment
Who cannot join
- Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs?
- Does he smoke more than 25 cigarettes/day?
- Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration?
- Does he have a history of seizure, cranial trauma, or other predisposition to seizure?
- Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety?
- Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety?
Show all 15Show fewer
- Does he have serious psychological illness?
- Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse?
- Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen?
- Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
- Has he used any prescription drug during the 14-day period prior to study initiation (except for topical products without systemic absorption), or any OTC drug during the 72-hour period preceding study initiation?
- Is he unable to refrain from the use of all concomitant medications during the study?
- Has he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- Has he donated plasma during the two week period preceding study initiation?
- Has he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.
The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) dose in fasted subjects.
Read the detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Abrika Bupropion 150 mg Extended-Released Tablet, Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
- Keywords
- Bioequivalence, Bupropion, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrika Bupropion 150 mg Extended-Released TabletDrug
Also called Bupropion
A: Experimental Subjects received Abrika formulated products under fasting conditions
Wellbutrin SR® 150 mg Extended-Release Tablet, single doseDrug
Also called Bupropion
B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Abrika Bupropion 150 mg Extended-Released Tablet, single dose Receives: Drug: Abrika Bupropion 150 mg Extended-Released Tablet |
| B | Active comparator | Wellbutrin SR® 150 mg Extended-Release Tablet, single dose Receives: Drug: Wellbutrin SR® 150 mg Extended-Release Tablet, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startAug 2004
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio R. Pizarro,, M.D., Principal investigator, SFBC Ft. Myers, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865410
- Sponsor's protocol ID
- 04-0646-009
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00865410
- Acronym / sponsor ID
- 04-0646-009
- Conditions
- Healthy
- Keywords
- Bioequivalence, Bupropion, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) dose in fasted subjects.
Detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Abrika Bupropion 150 mg Extended-Released TabletAbrika Bupropion 150 mg Extended-Released Tablet, single dose |
| B | Active comparator | Drug: Wellbutrin SR® 150 mg Extended-Release Tablet, single doseWellbutrin SR® 150 mg Extended-Release Tablet, single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is the individual a healthy, normal adult man who volunteers to participate?
- Is he 18-45 years of age, inclusive?
- Is his BMI ≤30?
- Is he considered reliable and capable of understanding his responsibility and role in the study?
- Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment
Key exclusion criteria (15 listed)
- Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs?
- Does he smoke more than 25 cigarettes/day?
- Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration?
- Does he have a history of seizure, cranial trauma, or other predisposition to seizure?
- Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety?
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 |
|---|---|---|
| Abrika Bupropion 150 mg Extended-Released TabletAlso: BupropionA: Experimental Subjects received Abrika formulated products under fasting conditions | Drug | A |
| Wellbutrin SR® 150 mg Extended-Release Tablet, single doseAlso: BupropionB: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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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.
Antonio R. Pizarro,, M.D. principal investigator
SFBC Ft. Myers, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abrika Bupropion 150 mg Extended-Released Tablet and Wellbutrin SR® 150 mg Extended-Release Tablet, single dose in people with Healthy, run by Actavis Inc. 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 5 inclusion and 15 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 16 Aug 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate and Extend of Absorption (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2010.