Bioequivalence study of mefenamic acid capsule 250 mg

Bioequivalence study of mefenamic acid 250 mg capsule of Jalinous pharmaceutical company compared to mefenamic acid 250 mg sample of Halo pharmaceutical company in the United States of America on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N16

Enrollment

Registered

2024-04-17

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-05-27

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 the oral consumption of 250 mg mefenamic acid capsules from Jalinous Pharmaceutical Company of Iran on 24 fasting healthy volunteers. 5 ml of blood are t

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
The maximum plasma concentration of mefenamic acid. Timepoint: Before taking the medicine and: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 10 hours after taking the medicine. Method of measurement: Liquid chromatography - spectrophotometric detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results