Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers

NCT06388239 | Not Yet Recruiting Phase 1

• 1 other identifier: BE24-006
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Keywords

Apixaban 5 mg; Bioequivalence Study; Healthy Thai Volunteers

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax) of Apixaban

  Maximum measured plasma concentration over the time span specified.

  Through 36 Hours Post Dose]

• Plasma Area Under the Curve AUC(0 to 36hr, AUC0-∞

  The area under the plasma concentration versus time curve.

  Through 36 Hours Post Dose]

Study Arms (2)

Apixaban 5 mg FCT

EXPERIMENTAL

Apixaban 5 mg Film-coated tablets Each tablet contains 5 mg apixaban

Drug: Apixaban 5MG

ELIQUIS

ACTIVE COMPARATOR

Apixaban 5 mg Film-coated tablets Each tablet contains 5 mg apixaban

Drug: Apixaban 5MG

Interventions

Apixaban 5MG DRUG

Apixaban 5 mg Film-coated tablets

Also known as: Apixaban

Apixaban 5 mg FCT; ELIQUIS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 1.
• 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 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. 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 2. 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
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
• Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
• Adequate venous access in both arms for the collection of a number of samples during the study

You may not qualify if:

• History of allergic reaction or hypersensitivity to apixaban or to any of the excipients
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
• History or evidence of clinically significant active bleeding
• Have abnormality of prothrombin time (PT) and activated partial thromboplastin time (aPTT) Have abnormality of prothrombin time (PT) and activated partial thromboplastin time (aPTT)
• History or evidence of hepatic disease associated with coagulopathy and clinically relevant bleeding risk
• Have lesion or condition if considered a significant risk factor for major bleeding including current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• History of problems with swallowing tablet or capsule
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
• History of diarrhea or vomiting within 24 hours prior to check-in in each period
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
• lead ECG demonstrating QTc \> 450 msec, a QRS interval \> 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
• Investigation with blood sample shows positive test for HBsAg.
• Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

apixaban

Study Officials

• Porranee Puranajoti, Ph. D

  International Bio Service Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanaporn Wongyai, M.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Paweena Boonprakong, B.Sc.

CONTACT

024415211; paweena.bon@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: August 26, 2024
• Primary Completion: September 14, 2024
• Study Completion: September 23, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share