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Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET in Healthy Subjects Under Fasting Conditions

NCT01910090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-07-29

No results posted yet for this study

Summary

To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé \& PEPCID® (Famotidine) 20mg Tablets, USP.

Conditions

  • Healthy

Interventions

DRUG

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

MULTI-LAYER TABLET

DRUG

ANTADYS® 100 mg, PEPCID® 20 mg

ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

Sponsors & Collaborators

  • Pharmaceutical Research Unit, Jordan

    lead OTHER

Principal Investigators

  • Dr. Rana T. Bustami, Ph.D. of Pharmacy · PRU

  • Dr. Rana T. Bustami, Ph.D. of Pharmacy · Dr. Rana T. Bustami

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910090 on ClinicalTrials.gov