Comparative in vivo evaluation of 2 formulations of Ibuprofen/Famotidine 800/26.6 mg Combined Tablet

?A Comparative bioequivalence study of two formulations of the Combined Tablet containing Ibuprofen/Famotidine 800/26.6 mg Tablet of Cosar Pharmaceutical Co. and Ibu & Famatidine of ASCEND Laboratories, L.L.C. as reference in 24 healthy volunteer under fasting.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N97

Enrollment

Registered

2025-10-05

Start date

2025-12-26

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Peptic ulcer, site unspecified. Peptic ulcer, site unspecified

Interventions

Intervention 1: Intervention group 1: Ibuprofen/Famotidine 800/26.6 mg Tablet , produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral do

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 18– 55 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. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal vital signs. Subjects who agree with patient consent form.

Exclusion criteria

Exclusion criteria: Subjects with known allergy to the products tested. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who has used any prescription or OTC drugs 14 days prior to the initiation of study and unable to refrain from the concomitant medications. History of alcohol or drug abuse Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. 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.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: 0? 0/5? 1? 1/5? 2? 2/5? 3? 3/5? 4? 4/5? 5? 6? 8? 10? 24 hour after administrating the dosage form. 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: 0? 0/5? 1? 1/5? 2? 2/5? 3? 3/5? 4? 4/5? 5? 6? 8? 10? 24 after administration. 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 and educational institute (Tavan)

info@tavaninstitute.ir+98 21 6600 7026

Outcome results

None listed

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