Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg

NCT05160090 | Completed Phase 1

• 1 other identifier: AMC-P7-739
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed concentration occurring at time Tmax

  Up to 96.00 hours

• AUC0-T

  Area under the concentration time curve from the time of last dosing to Tlast.

  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

  Up to 96.00 hours

Study Arms (2)

Test- BUPROPION HCl MR TABLETS 300mg

ACTIVE COMPARATOR

Single dose of Test- BUPROPION HCl MR TABLETS 300mg

Drug: Bupropion HCl MR tablets 300mg

Reference-Elontril 300 mg

ACTIVE COMPARATOR

Elontril 300 mg (Bupropion HCl MR tablets 300mg)

Drug: Bupropion HCl MR tablets 300mg

Interventions

Bupropion HCl MR tablets 300mg DRUG

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.

Also known as: Reference-Elontril (Bupropion HCl) MR tablets 300mg

Reference-Elontril 300 mg; Test- BUPROPION HCl MR TABLETS 300mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alembic Pharmaceuticals Ltd.: lead

Study Sites (2)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3H5, Canada

Location

Algorithme Pharma

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Eric Sicard, MD

  Clinical Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label (laboratory blind)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 16, 2021
• Study Start: January 18, 2020
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)