Investigating bioequivalence of Sofosbuvir/Velpatasvir tablet

In vivo fasted-state bioequivalence study of Sofosbuvir 400/Velpatasvir 100 tablet

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N11

Enrollment

Registered

2023-07-23

Start date

2023-08-06

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Sofosbuvir400/Velpatasvir 100 tablet manufactured by Bakhtar Bioshimi Co.) in fasted state. Bloo

Eligibility

Sex/Gender

Male

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age (18-59 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.33-72 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Valizadeh

Tabriz University of Medical Sciences

valizadehh@gmail.com+98 41 3334 8801

Outcome results

None listed

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