Bioequivalence study of apixaban 5 mg tablets

Bioequivalence study of apixaban 5 mg tablets from Kimia Ara Heram Pharmaceutical Company compared to apixaban 5 mg tablet from Pfizer Pharmaceutical Company, Germany, on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N23

Enrollment

Registered

2024-11-17

Start date

2024-11-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention 1: Intervention group 1: Includes oral administration of 5 mg apixaban tablets from Kimia Ara Heram Iran Pharmaceutical Company to 24 healthy fasting volunteers. 5 ml of blood is collecte

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer between 18 and 55 years old. Body mass index less than 30 kg per square meter. All candidates must be non-smokers.

Exclusion criteria

Exclusion criteria: Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg. Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug.

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of apixaban. Timepoint: Before starting the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24 and 48 hours after taking the drug. Method of measurement: Liquid chromatography - mass spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results