Depressive DisorderPhase 1NCT01046214
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
A Phase 1 study testing Bupropion HCl in people with Depressive Disorder, run by Teva Pharmaceuticals USA at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Bupropion HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to not given
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 25 years of age or older
- Diagnosis of any depressive disorder as per DSM IV criteria (except bipolar depression and major depressive disorder with psychotic features). Note: Both patients who are or are not being treated with bupropion or other antidepressants are permitted into the study.
- Patients must have complained of suffering from adverse events and/or lack of effect when switched from Wellbutrin XL® 300 mg to Budeprion XL™ 300 mg.
- BMI (kg/m2) Greater than or equal to 19 and less than or equal to 34.
- No clinically significant abnormal laboratory values
- No clinically significant findings in a 12-lead electrocardiogram (ECG)
- No clinically significant findings in vital signs measurements.
- Be informed of the nature of the study and give written consent prior to receiving any study procedure.
Who cannot join
- Carcinoma within the last 5 years. Note: Patients with basal or squamous cell carcinoma may be permitted into the study on a case by case basis.
- A history of epilepsy or risk for seizures.
- A previous or current diagnosis of bipolar depression.
- A current diagnosis of major depressive episode with psychotic features. Note: Subjects with previous diagnosis of major depressive episode with psychotic features may be included at the investigator's discretion.
- A previous or current diagnosis of an eating disorder (e.g. bulimia, anorexia nervosa).
- A lifetime history of schizophrenia or schizo-affective disorder.
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- Significant disease(s) or clinically significant finding(s) in a physical examination determined by an investigator to pose a health concern to the patient while on study.
- Presence of clinically significant gastrointestinal disease and/or surgery (e.g. gastric bypass surgery) or history of malabsorption within the last year.
- Known history or presence of an allergic sensitivity to bupropion and/or any other drug substances with similar activity.
- Expected changes in use of permitted concomitant medication that will be continued throughout the study.
- Undergoing abrupt discontinuation of sedatives (including benzodiazepines).
- Use of monoamine oxidase inhibitors (MAOI) within 2 weeks prior to study admission.
- Taking medications that interact with CYP2B6 within 30 days prior to Day 1 dosing.
- Taking levodopa, amantadine, drugs that lower seizure threshold (e.g. theophylline, systemic steroids, antipsychotics), and/or on nicotine replacement therapy.
- History of alcohol or drug-dependence by DSM IV criteria within 6 months prior to study admission.
- Positive test results for:
- HIV
- Hepatitis B surface antigen or Hepatitis C antibody
- Urine drugs of abuse (i.e. marijuana, amphetamines, barbiturates, cocaine, opiates, methadone, and phencyclidine) Note: any positive test result(s) for benzodiazepine(s) must be assessed by the investigator to determine whether the patient should be excluded from this study.
- Serum hCG consistent with pregnancy (females only).
- On a special diet within 30 days prior to study admission (e.g. liquid, protein, raw food diet).
- Difficulty fasting or consuming standard meals.
- Participated in another clinical trial or received an investigational product within 45 days prior to Day 1 drug administration.
- Donation or loss of whole blood:
- Less than or equal to 499 mL within 30 days prior to dosing
- Greater than or equal to 500 mL within 56 days prior to dosing Note: blood taken for routine medical evaluations totaling less than 50 mL will be permitted.
- Females who have discontinued the use of:
- implanted, intrauterine, or injected hormonal contraceptives within 6 months prior to Day 1 drug administration, OR
- oral, intravaginal, or patch hormonal contraceptives within 1 month prior to Day 1 drug administration
- Females who started taking:
- implanted or intrauterine hormonal contraceptives less than 6 months prior to Day 1 drug administration, OR
- oral, intravaginal, patch, or injected hormonal contraceptives less than 3 months prior to Day 1 drug administration.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- Have had a newly applied tattoo or body piercing within 30 days prior to study admission.
- Does not tolerate venipuncture.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
California Clinical Trials
Culver City, California, 90232
California Clinical Trials
Glendale, California, 91206
About this study
Official title: A Multiple-Dose, Double Blind, Double Dummy, Comparative Bioavailability Study of Two Formulations of Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.
- Conditions
- Depressive Disorder
- Being tested
- Bupropion HCl
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion HClDrug
Also called Budeprion XL™
Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet
Bupropion HClDrug
Also called Wellbutrin XL®
Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Budeprion XL™ | Experimental | Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet Receives: Drug: Bupropion HCl |
| Wellbutrin XL® | Active comparator | Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet Receives: Drug: Bupropion HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative bioavailability
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lev Gertsik, MD, Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046214
- Sponsor's protocol ID
- 2008-1668
- Status last verified
- Nov 2015
- First submitted
- 8 Jan 2010
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Double Blind, Double Dummy, Comparative Bioavailability Study of Two Formulations of Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01046214
- Acronym / sponsor ID
- 2008-1668
- Conditions
- Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- First posted
- 11 Jan 2010 (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 objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budeprion XL™ | Experimental | Drug: Bupropion HClBudeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet |
| Wellbutrin XL® | Active comparator | Drug: Bupropion HClWellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, 25 years of age or older
- Diagnosis of any depressive disorder as per DSM IV criteria (except bipolar depression and major depressive disorder with psychotic features). Note: Both patients who are or are not being treated with bupropion or other antidepressants are permitted into the study.
- Patients must have complained of suffering from adverse events and/or lack of effect when switched from Wellbutrin XL® 300 mg to Budeprion XL™ 300 mg.
- BMI (kg/m2) Greater than or equal to 19 and less than or equal to 34.
- No clinically significant abnormal laboratory values
Key exclusion criteria (36 listed)
- Carcinoma within the last 5 years. Note: Patients with basal or squamous cell carcinoma may be permitted into the study on a case by case basis.
- A history of epilepsy or risk for seizures.
- A previous or current diagnosis of bipolar depression.
- A current diagnosis of major depressive episode with psychotic features. Note: Subjects with previous diagnosis of major depressive episode with psychotic features may be included at the investigator's discretion.
- A previous or current diagnosis of an eating disorder (e.g. bulimia, anorexia nervosa).
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 |
|---|---|---|
| Bupropion HClAlso: Budeprion XL™Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet | Drug | Budeprion XL™ |
| Bupropion HClAlso: Wellbutrin XL®Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet | Drug | Wellbutrin XL® |
Primary outcome
Comparative bioavailability
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Lev Gertsik, MD principal investigator
California Clinical Trials
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupropion HCl in people with Depressive Disorder, run by Teva Pharmaceuticals USA at 2 sites 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 8 inclusion and 36 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: stopped early, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Recruitment issues). Results are not available in the source record.
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?
Comparative bioavailability (time frame: 1 month). 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 20 Nov 2015.