Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511731

Enrollment

Registered

2012-01-19

Start date

1998-10-31

Completion date

1998-10-31

Last updated

2012-01-19

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

Conditions

Healthy

Keywords

Bioequivalence, famotidine, Crossover

Brief summary

The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.

Detailed description

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Interventions

DRUGFamotidine

Famotidine Tablets 40 mg

DRUGPepcid

40mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Exclusion criteria

History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: * alcoholism or drug abuse within the past year; * hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. Subjects who, through completion of the study, would have donated in excess of: * 500 mL of blood in 14 days, or * 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator), * 1000 mL of blood in 90 days, * 1250 mL of blood in 120 days, * 1500 mL of blood in 180 days, * 2000 mL of blood in 270 days, * 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.

Design outcomes

Primary

Measure	Time frame
Area Under Curve (AUC)	predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026