Trials Sponsors Conditions Drugs Pricing

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The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000,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The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000,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The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000,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 5MGDrug

Each film-coated tablet contains 5 mg apixaban

Apixaban 5 mg Film Tablets

Eliquis 5 mgDrug

Each film-coated tablet contains 5 mg apixaban

Eliquis 5 mg Film tablets

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Yunus sancak
Type not reportedcollaborator
Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

MeSH Terms

Interventions

apixaban

Study Officials

Hakan Gürpınar
Humanis Saglık
STUDY DIRECTOR

Enrollment

30 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Apixaban 5 mg Film Tablets

Eliquis 5 mg Film tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Apixaban 5 mg Film Tablets

Eliquis 5 mg Film tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations