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Bioequivalence study of Favipiravir 200mg tablet of Actover Co., IRAN

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Favipiravir 200mg tablet of Actover Co., IRAN and Avigan 200mg tablet of Toyoma Chemical in 24 healthy adult subjects under fasting condition

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190706044111N26
Enrollment
24
Registered
2022-01-05
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-01-11

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

Conditions

COVID-19. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: Favipiravir, one 200mg tablet, produced by Actover Co. (IRAN), single dose. Intervention 2: Control group: Avigan, one 200mg tablet, produced by Toyoma Chemical com

Sponsors

Actover Pharm. Co.
Lead Sponsor

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 treatment. Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first 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

MeasureTime frame
Plasma concentration of favipiravir following administration of one tablet of 200mg favipiravir. Timepoint: at 0 (before dosing), 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 &10.0hr. 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