Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects

NCT06043297 | Completed Phase 1

• 1 other identifier: 0335-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under fasting condition and to assess the bioequivalence.

Conditions

Antithrombic Drug

Outcome Measures

Primary Outcomes (2)

• Cmax

  The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

• AUC0-t

  The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

Secondary Outcomes (1)

• AUC0-∞

  The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

Study Arms (2)

Apixaban 5 mg Film Tablets

EXPERIMENTAL

Drug: Apixaban 5MG

Eliquis 5 mg Film tablets

ACTIVE COMPARATOR

Drug: Eliquis 5 mg

Interventions

Apixaban 5MG DRUG

Each film-coated tablet contains 5 mg apixaban

Apixaban 5 mg Film Tablets

Eliquis 5 mg DRUG

Each film-coated tablet contains 5 mg apixaban

Eliquis 5 mg Film tablets

Eligibility Criteria

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

You may qualify if:

• Non-smoker, normal, healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
• Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in m2 and body weight ≥ 60 kg.
• Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (posterior-anterior view).
• aPTT and PT within normal range.
• Able to understand and comply with the study procedures, in the opinion of the investigator.
• Able to give voluntary written informed consent for participation in the trial.
• In case of female subjects:
• Surgically sterilized at least 6 months prior to study participation.
• If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
• And -Serum pregnancy test must be negative.

You may not qualify if:

• Known hypersensitivity to Apixaban or any excipients or any related drug or any substance.
• History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
• Ingestion of medicine \[prescribed \& over the counter (OTC) medication including herbal remedies, anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs) or serotoninnorepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory medicinal products (NSAIDs) including acetylsalicylic acid, inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp), such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole)and HIV protease inhibitors (e.g., ritonavir) and Inducers of CYP3A4 and P-gp (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) and any vaccine (including COVID-19 vaccine)\] at any time within 14 days prior to dosing of Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
• CrCl value \< 50 mL/min
• Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
• A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.), or consumption of alcohol or alcoholic product within 48 hours prior to receiving study medicine of Period-I.
• Smokers or who have smoked within last 06 months prior to start of the study.
• The presence of clinically significant abnormal laboratory values during screening.
• Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
• History or presence of seizure or psychiatric disorders.
• A history of difficulty with donating blood.
• Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
• Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication\*\*.
• \*\* If investigational medicinal product is received within 90 days where there is no blood loss except safety laboratory testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead
• Yunus sancak: collaborator

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

Location

MeSH Terms

Interventions

apixaban

Study Officials

• Hakan Gürpınar

  Humanis Saglık

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: February 23, 2023
• Primary Completion: March 6, 2023
• Study Completion: April 27, 2023
• Last Updated: September 15, 2025

Record last verified: 2023-12

Locations

IN (1)