A Single Dose, Randomized, Open-label, Two-period, Two-sequence Crossover Bioequivalence Study of Generic Apixaban 5 mg Film-coated Tablets and Reference Product (ELIQUIS) in Healthy Thai Volunteers Under Fasting Conditions

International Bio service0 sites28 target enrollmentAugust 26, 2024

ConditionsHealthy Volunteer

InterventionsApixaban 5MG

DrugsApixaban 5MG

Overview

Phase: Phase 1
Intervention: Apixaban 5MG
Conditions: Healthy Volunteer
Sponsor: International Bio service
Enrollment: 28
Primary Endpoint: Peak Plasma Concentration (Cmax) of Apixaban
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUIS (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2.

Detailed Description

Twenty-eight (28) healthy adult male and female volunteers (preferably with approximately equal numbers of each sex, if possible) 18 to 55 years will be enrolled from the general population. Healthy adult male and female volunteers will be recruited in bioequivalence study as recommended in United States (US) Food and Drug Administration (FDA), Draft Guidance on Apixaban. (11) Apixaban is a drug that can be used in any sex. By these reasons, normal healthy males and females as general population will be screened and 28 subjects will be recruited and enrolled into the study. An attempt will be made by clinical study team to recruit subjects as per requirement. Remark: The expected ratio of male to female subjects is 1:1; however, if necessary, the ratio can be varied but not more than 25% each.

Registry

clinicaltrials.gov

Start Date

August 26, 2024

End Date

September 23, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

International Bio service

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period
•Body mass index between 18.5 to 30.0 kg/m2
•Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
•Non-smoker and non-consumer of nicotine containing products Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
•Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
•Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period
•Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period
•Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period
•Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
•Postmenopausal for at least 1 year or