In-Vivo Bioequivalence study

In-vivo Bioequivalence Study of Ibuprofen 600 mg ER. Tablets of The Test Drug (ADVALGIN® ER 600 mg Tab., Abidi Pharma, Iran) in Compared with The Reference Drug (ADVIL® ER 600 mg, Wyeth Pharmaceuticals, USA) In Iranian Healthy Volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N124

Enrollment

Registered

2024-09-26

Start date

2024-09-14

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

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

Interventions

Intervention 1: Intervention group: Single-dose of the test drug Ibuprofen 600 mg ER. Tablet (ADVALGIN ER 600 mg Tab., Abidi Pharma, Iran) in the first period. Intervention 2: Control group: Single-do

Eligibility

Sex/Gender

All

Age

18 Years to 60 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
Plasma concentration of the drug. Timepoint: After blood sampling. Method of measurement: HPLC-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