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Bioequivalence study of warfarin 5 mg tablet manufactured by Mahban darou Co. on 24 healthy volunteers and comparing with coumadin as reference tablet manufactured by Bristol Myer

Bioequivalence study of warfarin 5 mg tablet manufactured by Mahban darou Co. on 24 healthy volunteers and comparing with coumadin as reference tablet manufactured by Bristol Myer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240911063007N1
Enrollment
24
Registered
2024-10-02
Start date
2024-11-05
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

Cardiovascular disease. Atrial fibrillation and flutter

Interventions

Intervention 1: Intervention group- In the first period each volunteers in the first group are receiving one 5 mg warfarin tablet manufactured by Mahban Darou, and the volunteers in second group are r

Sponsors

Mahban Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Physical Health

Exclusion criteria

Exclusion criteria: Taking certain drugs Alcohol consumption

Design outcomes

Primary

MeasureTime frame
Plasma Concentration. Timepoint: In 0? 15? 30? 45? 60?90 minutes and 2? 3? 4? 6? 8? 12? 24? 48? 72 hours. Method of measurement: Liquid Chromatography Mass Spectrometry method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Kobarfard

Shahid Beheshti University of Medical Sciences

farzadkf@yahoo.com+98 21 8820 0092

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026