Bioeqivalence study of amlodipine valsartan 10/160 mg tablet

Bioequivalence Study of amlodipine valsartan 10/160 mg manufactured by Alborz Darou and Exforge manufactured by Novartis in 24 Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220209053979N5

Enrollment

Registered

2023-02-04

Start date

2023-02-23

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Bioequivalence study.

Interventions

Intervention 1: Intervention group: 1 oral administration of one amlodipine valsartan 10/160 mg tablet manufactured by Alborz Daru Company to 12 healthy volunteers in fasting state with 240 ml of wate

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Laboratory tests +/- 10% of normal interval without any history of chronic sickness

Exclusion criteria

Exclusion criteria: Systolic blood pressure less than 90 and diastolic less than 60 mm Hg Smoking more than 10 cigarette per day

Design outcomes

Primary

Measure	Time frame
Plasma concentration time profile,. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.	—

Secondary

Measure	Time frame
Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Pharmacokientic parameters are calculated by excel.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Talari

Kharazmi Plasma Center

talari_r@yahoo.com+98 21 5669 4726

Outcome results

None listed

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