BioequivalencePhase 1NCT05160090
Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg
A Phase 1 study testing Bupropion HCl MR tablets 300mg in people with Bioequivalence, run by Alembic Pharmaceuticals Ltd. at 2 sites in Canada.
Trial summary
The objective of this study is to determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the Test and Reference formulations in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Bupropion HCl MR tablets 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jan 2020to 5 Feb 2020
- 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
- Provision of signed and dated informed consent form (ICF)
- Subjects able to communicate effectively with study personnel
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If female, meets 1 of the following criteria
- Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include Abstinence from heterosexual intercourse from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug
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- 1 of the following highly-effective contraceptive methods, used from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug Intrauterine device (without hormones) Male partner vasectomized at least 6 months prior to the first study drug administration Male condom with spermicide In addition of the male condom with spermicide, female needs to use an additional method from the first study drug administration through to at least 30 days after the last dose of the study drug Diaphragm/cervical cap Or
- Male partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable contraceptive method from the first study drug administration through to at least 30 days after the last dose of the study drug Or
- Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)
- Aged at least 18 years but not older than 45 years
- Body mass index (BMI) greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2
- Minimal body weight of 60 kg
- Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator
Who cannot join
- Female who is lactating at screening
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- Difficulty with donating blood due to bad veins
- Difficulty in swallowing tablets or capsules
- Seated blood pressure lower than 100/60 mmHg at the screening visit and prior to the first study drug administration
- History of significant hypersensitivity to bupropion or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
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- Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening (APPENDIX 6 COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) BASELINE/SCREENINGVERSION)
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTcF > 440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by an investigator
- Use of concomitant medications that lower seizure threshold, including but not limited to: antipsychotics, antidepressants, lithium, amantadine, theophylline, systemic steroids, quinolone antibiotics, and anti-malarials
- Use of over-the-counter stimulants or anorectics
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- Any history of tuberculosis
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
- Inclusion in a previous group for this clinical study
- Intake of bupropion in the 28 days prior to the first study drug administration
- Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
- Intake of an IP in another clinical trial with a long half-life (≥120 hours) in the previous 90 days prior to the first study drug administration
- Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Algorithme Pharma Inc.
Mount Royal, Quebec, H3P 3H5
Algorithme Pharma
Mount Royal, Quebec, H3P 3P1
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of Bupropion Hydrochloride Modified Release Tablet 300mg In Healthy Adult Subjects / Fasting State
The objective of this study is to determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions.
The secondary objective of this study is to evaluate the safety and tolerability of the Test and Reference formulations in healthy subjects.
Read the detailed description
This is a single center, randomized, 2-treatment, 2-period, 2-sequence, crossover, single dose study design, in which 34 healthy adult subjects will receive 1 of the study treatments during each study period.
Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 10 hours prior to drug administration for each study period.
For each study period, subjects will receive a single 300 mg oral dose of bupropion, under fasting conditions and undergo a 96-hour PK sample collection. Subjects are to be discharged from the clinic after the 36-hour postdose PK sample collection, and following medical approval. However, they may be advised to stay at the clinical site for safety reasons, if judged necessary by the physician in charge. Subjects will return to the clinic for blood collections at 48, 72, and 96 hours postdose.
The drug administrations in each period will be separated by at least 14 calendar days.
The duration of the clinical portion of this study (excluding the screening period) is expected to be approximately 19 days. The actual overall study duration may vary.
Tests during study:
An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as before discharge of each period. Neurologic Function Test will be performed at screening, approximately 26 hours after each drug administration \& end of the study.
For female subjects, a serum pregnancy test will be performed before each period of the study \& end of study.
Vital signs will be measured prior to and approximately 2.5, 4, 6, 12, 24, and 36 hours following each drug administration.
Safety assessments will include physical examination, vital signs, clinical laboratory tests, neurologic function tests, and AE monitoring. Additional safety measurements may be performed at the discretion of the investigator for reasons related to subject safety.
The physician in charge will be present at the clinical site for at least the first 6 hours following each drug administration and will remain available at all times throughout the study.
Post study Tests:
Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study.
A complete physical examination (including vital signs) will also be performed.
Bioanalysis: Bupropion \& its metabolites plasma concentrations will be measured by a validated bioanalytical method.
Standards for Bioequivalence:
Statistical inference of bupropion will be based on a bioequivalence approach using the following standards:
The ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and Reference products for the ln-transformed parameters Cmax, AUC0-T, AUC0-∞, should all be within the 80.00 to 125.00% bioequivalence range.
For the metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) , the same criteria will be applied and the results will be presented as supportive evidence of comparable therapeutic outcome.
- Conditions
- Bioequivalence
- Being tested
- Bupropion HCl MR tablets 300mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion HCl MR tablets 300mgDrug
Also called Reference-Elontril (Bupropion HCl) MR tablets 300mg
In each study period, a single 300 mg dose of Bupropion will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Test- BUPROPION HCl MR TABLETS 300mg | Active comparator | Single dose of Test- BUPROPION HCl MR TABLETS 300mg Receives: Drug: Bupropion HCl MR tablets 300mg |
| Reference-Elontril 300 mg | Active comparator | Elontril 300 mg (Bupropion HCl MR tablets 300mg) Receives: Drug: Bupropion HCl MR tablets 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration occurring at time Tmax
Measured: Up to 96.00 hours
AUC0-T
Area under the concentration time curve from the time of last dosing to Tlast.
Measured: Up to 96.00 hours
AUC0-∞
Area under the concentration time curve extrapolated to infinity, calculated as AUCT + ĈLQC/λZ, where ĈLQC is the predicted concentration at time Tlast
Measured: Up to 96.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Jan 2020
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alembic Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Clinical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160090
- Sponsor's protocol ID
- AMC-P7-739
- Status last verified
- May 2022
- First submitted
- 22 Nov 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Crossover Comparative Bioavailability Study of Bupropion Hydrochloride Modified Release Tablet 300mg In Healthy Adult Subjects / Fasting State
- ClinicalTrials.gov ID
- NCT05160090
- Acronym / sponsor ID
- AMC-P7-739
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Alembic Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 16 Dec 2021 (actual)
- 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 determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions.
The secondary objective of this study is to evaluate the safety and tolerability of the Test and Reference formulations in healthy subjects.
Detailed description
This is a single center, randomized, 2-treatment, 2-period, 2-sequence, crossover, single dose study design, in which 34 healthy adult subjects will receive 1 of the study treatments during each study period.
Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 10 hours prior to drug administration for each study period.
For each study period, subjects will receive a single 300 mg oral dose of bupropion, under fasting conditions and undergo a 96-hour PK sample collection. Subjects are to be discharged from the clinic after the 36-hour postdose PK sample collection, and following medical approval. However, they may be advised to stay at the clinical site for safety reasons, if judged necessary by the physician in charge. Subjects will return to the clinic for blood collections at 48, 72, and 96 hours postdose.
The drug administrations in each period will be separated by at least 14 calendar days.
The duration of the clinical portion of this study (excluding the screening period) is expected to be approximately 19 days. The actual overall study duration may vary.
Tests during study:
An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as before discharge of each period. Neurologic Function Test will be performed at screening, approximately 26 hours after each drug administration \& end of the study.
For female subjects, a serum pregnancy test will be performed before each period of the study \& end of study.
Vital signs will be measured prior to and approximately 2.5, 4, 6, 12, 24, and 36 hours following each drug administration.
Safety assessments will include physical examination, vital signs, clinical laboratory tests, neurologic function tests, and AE monitoring. Additional safety measurements may be performed at the discretion of the investigator for reasons related to subject safety.
The physician in charge will be present at the clinical site for at least the first 6 hours following each drug administration and will remain available at all times throughout the study.
Post study Tests:
Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study.
A complete physical examination (including vital signs) will also be performed.
Bioanalysis: Bupropion \& its metabolites plasma concentrations will be measured by a validated bioanalytical method.
Standards for Bioequivalence:
Statistical inference of bupropion will be based on a bioequivalence approach using the following standards:
The ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and Reference products for the ln-transformed parameters Cmax, AUC0-T, AUC0-∞, should all be within the 80.00 to 125.00% bioequivalence range.
For the metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) , the same criteria will be applied and the results will be presented as supportive evidence of comparable therapeutic outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
| Arm | Type | Receives |
|---|---|---|
| Test- BUPROPION HCl MR TABLETS 300mg | Active comparator | Drug: Bupropion HCl MR tablets 300mgSingle dose of Test- BUPROPION HCl MR TABLETS 300mg |
| Reference-Elontril 300 mg | Active comparator | Drug: Bupropion HCl MR tablets 300mgElontril 300 mg (Bupropion HCl MR tablets 300mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form (ICF)
- Subjects able to communicate effectively with study personnel
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If female, meets 1 of the following criteria
Key exclusion criteria (24 listed)
- Female who is lactating at screening
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- Difficulty with donating blood due to bad veins
- Difficulty in swallowing tablets or capsules
- Seated blood pressure lower than 100/60 mmHg at the screening visit and prior to the first study drug administration
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 HCl MR tablets 300mgAlso: Reference-Elontril (Bupropion HCl) MR tablets 300mgIn each study period, a single 300 mg dose of Bupropion will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast. | Drug | Reference-Elontril 300 mg, Test- BUPROPION HCl MR TABLETS 300mg |
Primary outcome
Cmax
Time frame: Up to 96.00 hours
Maximum observed concentration occurring at time Tmax
AUC0-T
Time frame: Up to 96.00 hours
Area under the concentration time curve from the time of last dosing to Tlast.
AUC0-∞
Time frame: Up to 96.00 hours
Area under the concentration time curve extrapolated to infinity, calculated as AUCT + ĈLQC/λZ, where ĈLQC is the predicted concentration at time Tlast
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 9 May 2022.
- Individual participant dataSharing planned: No
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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.
Eric Sicard, MD principal investigator
Clinical Investigator
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 MR tablets 300mg in people with Bioequivalence, run by Alembic Pharmaceuticals Ltd. at 2 sites in Canada.
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 15 inclusion and 24 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 9 May 2022. 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 Canada. 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?
Cmax (time frame: Up to 96.00 hours). The study lists 3 primary outcomes in all. 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 9 May 2022.