Vivo Bioequivalence study

In Vivo Bioequivalence study of Sumatriptan/Naproxen Pars-Gita Darou (MigrExtra® 500/85 mg ) with brand drugs (TREXIMET®500/85 mg) Currax Pharmaceuticals LLC in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N117

Enrollment

Registered

2024-08-26

Start date

2024-09-18

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

In this study the bioequivalence of test and brand of MigrExtra® will be evaluated..

Interventions

Control group: Intervention group: Single-dose (TREXIMET® Tabs. 85/500 mg. Currax Pharma, UK ) as reference product..

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC,LC-MS/MS or UPLC-MS/MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Nemati

Radin Shimi Co.

shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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