Bioequivalence study of Valsartan 160 mg

Bioequivalence study of Valsartan 160mg manufactured by Sanamed company in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N5

Enrollment

Registered

2021-07-11

Start date

2021-08-05

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Healthy volunteers.

Interventions

Intervention 1: Intervention group: single dose, Diovan 160 mg tablet, Novartis, as reference product. Intervention 2: Intervention group: Single dose, Valsartan 160mg, Sanamed company, as test produc

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart and Kidney) Body Mass Index (18-28) Informed consent Age (18-60 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcoholism and Narcoticism History of allergy to Valsartan

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: Hour. Method of measurement: blood sampling.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 21 6640 3568

Outcome results

None listed

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