Bioequivalence study of Febuxostat 80mg tablet of Kimiara Heram Pharm Co., IRAN

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Febuxostat 80mg tablet of Kimiara Heram Pharm Co., IRAN in comparison of Adenuric 80mg tablet of Menarini in 24 healthy adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N20

Enrollment

Registered

2021-04-20

Start date

2021-10-23

Completion date

Unknown

Last updated

2021-05-26

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

Conditions

Gout. Hyperuricemia (high uric acid in blood)

Interventions

Intervention 1: Intervention group: Febuxostat, one 80mg tablet, produced by Kimiara Heram Pharm Co (IRAN), single dose. Intervention 2: Control group: Adenuric, one 80mg tablet, produced by Menarini

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Aged between 18 - 50 years - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examination - Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of Febuxostat. Timepoint: at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing. Method of measurement: High Performance Liquid Chromatography (HPLC).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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