Bioequivalence study of Famotidine 40 mg

Bioequivalence study of Famotidine 40 mg tablet manufactured by Sanamed company versus the originator brand in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N14

Enrollment

Registered

2022-01-22

Start date

2024-11-20

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

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: single dose, one oral tablet 40mg (Pepcid) manufactured by Merck, as a reference product. Intervention 2: Intervention group: Single dose, one oral Famotidine 40mg

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to Famotidine

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0; 0.33; 0.67; 1; 1.33;01.67; 2; 2.33; 2.67, 3; 3.5; 4; 6; 8; 10; 12h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

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