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Bioequivalence of Valsartan tablets

Single-dose bioequivalence studies of Valsartan tablets (160 mg) in healthy volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170717035129N1
Enrollment
26
Registered
2021-02-11
Start date
2021-02-12
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Healthy subjects.

Interventions

Intervention 1: Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 160 mg Valsartan tablets made by Hakim Company during a treatment period. Aft

Sponsors

Hakim Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer Age: 18-50 year

Exclusion criteria

Exclusion criteria: History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2

Design outcomes

Primary

MeasureTime frame
Plasma drug concentration. Timepoint: 0.33, 0.66, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24 Hours. Method of measurement: High performance liquid chromatography (HPLC) method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Haeri

Shahid Beheshti University of Medical Sciences

a_haeri@sbmu.ac.ir+98 21 8820 0212

Outcome results

None listed

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