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In-vivo Bioequivalence Study of Mefenamic Acid 250 mg Hard Gelatine Capsules of The Test Drug (Sajjad Darou, Iran)

In-vivo Bioequivalence Study of Mefenamic Acid 250 mg Hard Gelatine Capsules of The Test Drug (Sajjad Darou, Iran) in Compared with The Reference Drug (PONSTAN® 250 mg. Caps. Pfizer, Swiss) In Iranian Healthy Volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N159
Enrollment
24
Registered
2025-10-24
Start date
2025-12-06
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: Single-dose of Mefenamic Acid 250 mg Hard Gelatine Capsules of The Test Drug (Sajjad Darou, Iran) , in the first period. Cross-over design with one week wash out pe

Sponsors

Sajad darou shargh
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) of volunteers Informed consent form Body mass index range (18-30) Age between18-55

Exclusion criteria

Exclusion criteria: Smoking Having a history of cardiovascular disease Having a history of liver & kidney disease Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy

Design outcomes

Primary

MeasureTime frame
The concentration of the drug in blood. Timepoint: 0.5 ,1, 2 ,2.5 , 3, 3.5 , 4 , 4.5 , 5 , 5.5 , 6 , 7 , 8 , 10, 12 and 24 h after drug. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

MeasureTime frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the device analysis of the samples and through the WinNonLine software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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