NCT01511731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
13.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

January 12, 2012

Last Update Submit

January 18, 2012

Conditions

Healthy

Keywords

BioequivalencefamotidineCrossover

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Famotidine

EXPERIMENTAL

Famotidine tablets 40 mg of Dr. Reddy's

Drug: Famotidine

Pepcid

ACTIVE COMPARATOR

Pepcid 40 mg Tablets of Merck \& Co.,

Drug: Pepcid

Interventions

FamotidineDRUG

Famotidine Tablets 40 mg

Also known as: Reddy Cheminor
Famotidine
PepcidDRUG

40mg tablets

Also known as: Merck & Co.
Pepcid

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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:
  • mL of blood in 14 days, or
  • mL of blood in 14 days (unless approved by the Principal Investigator),
  • mL of blood in 90 days,
  • mL of blood in 120 days,
  • mL of blood in 180 days,
  • mL of blood in 270 days,
  • mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Clinical Research Center

Montreal, Canada

Location

MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Samuel Serfaty, MD

    Phoenix Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 19, 2012

Study Start

October 1, 1998

Primary Completion

October 1, 1998

Study Completion

October 1, 1998

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

CA(1)