Bioequivalence study of amlodipine (as besylate) and valsartan 160/10 mg tablets

Bioequivalence study of Amlodipine (as besylate) Valsartan 160/10 mg tablets from Samisaz Pharmaceutical Company compared to Amlodipine (as besylate) Valsartan 160/10 mg tablets from Novartis Company, Turkey, under license from Switzerland, on healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N20

Enrollment

Registered

2024-10-28

Start date

2024-10-27

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

None listed

Interventions

Intervention 1: Intervention group 1: Includes oral administration of amlodipine (as besylate) valsartan 10/160 mg tablets from Samisaz Pharmaceutical Company, Iran, on 24 healthy fasting volunteers.

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers aged between 18 and 55 years. Body mass index less than 30 kg per square meter. All candidates must be non-smokers.

Exclusion criteria

Exclusion criteria: Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg. Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug.

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentrations of amlodipine (as besylate) and valsartan. Timepoint: Before starting the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 6.5, 7, 7.5, 8, 10, 24, 48 and 72 hours after taking the drug. Method of measurement: Liquid chromatography-mass spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results