In-vivo Bioequivalence Test of Daclaasvir/Sofosbuvir 60/400 mg Actero Middle East with brand drug (Sofosbovir/Daclatasivir® 400/60 mg, Mylan, Germany)

In- Vivo Bioequivalence study of Daclaasvir/Sofosbuvir 60/400 mg Actero Middle East Pharma (DATEX 400/60 mg Tab.) with brand drug (Sofosbovir/Daclatasivir® 400/60 mg, Mylan, Germany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N68

Enrollment

Registered

2022-09-05

Start date

2022-09-03

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group 1: One test tablet (Daclaasvir/Sofosbuvir 60/400 mg produced by Actro Middle East Pharma) will be received. Blood samples will be taken for 72 hours at the mentioned

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old

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 drug concentration. Timepoint: Sampling times in this study will be ? 0.25? 0.5? 0.75? 1? 1.25? 1.5? 1.75? 2? 2.5? 3? 4? 6? 8? 10? 24 48 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Baspar Teyf Gostar Company

Dariush Omidfar

Dariush.omidfar@gmail.com+98 41 3384 2724

Outcome results

None listed

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