Comparative in vivo evaluation of 2 Finasteride 1 mg Tablet formulations.

Comparative bioequivalence study of Finasteride 5 mg Tablet of Iran Hormone. and Finasteride® of 1A Pharma GmbH as reference in 24 healthy male under fasting.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N71

Enrollment

Registered

2024-11-02

Start date

2024-11-25

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

Enlarged prostate. Enlarged prostate

Interventions

Intervention 1: Intervention group1:(Test) Finasteride 1 mg tablet, produced by Iran Hormone Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of

Eligibility

Sex/Gender

Male

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age. Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.

Exclusion criteria

Exclusion criteria: Subjects with known allergy to Tested Product.Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study. Married candidates are advised to strictly refrain from sexual intercourse during the test and in the sampling interval.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Montaha sangari

Noor Research & Development Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

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