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

July 24, 2013 updated by: Pharmaceutical Research Unit, Jordan

Comparative, Randomized, Two-period, Two-treatment, Two-sequence, Single Dose, Open-label, Crossover Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET (One Tablet) of (Sanovel İlaç San. ve Tic. A.Ş., İstanbul / Türkiye) Versus ANTADYS® Flurbiprofen 100 mg Comprimé Pelliculé (One Film-coated Tablet) of (LaboratoireThẻramex 6, Avenue Albert II- BP.59 98007 MONACO Cedex) and PEPCID® (Famotidine) 20 mg Tablets, USP (One Tablet) of (Marathon Pharmaceuticals, LLC USA) in Healthy Subjects Under Fasting Conditions

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.

Study Overview

Detailed Description

An open-label, randomized, single dose, two-treatment, two-period, two-sequence, crossover bioequivalence with a washout period of at least 7 days between doses Healthy mixed skin Arab & Mediterranean Subjects ages between 18 and 45 years, body-mass index 18.5 to 30.0 kg/m2 inclusive, non-smokers or light smokers (smokers of not more than 10 cigarettes per day).

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amman, Jordan, 00962
        • Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy Male subjects.
  2. Ethnic Group: Arab & Mediterranean
  3. Race: Mixed skin (white & black skin people).
  4. Age 18-45 years
  5. Body-mass index 18.5 to 30.0 kg/m2 inclusive
  6. Subject is available for the whole study period and gave written informed consent
  7. Physical examination within normal ranges
  8. All laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician.
  9. Vital signs within normal ranges (Unless clinical investigator classified as insignificant).
  10. Normal Kidney & Liver function tests (Unless clinical investigator classified as insignificant).
  11. Normal Cardiovascular system.
  12. Normal Digestive system.

Exclusion Criteria:

  1. Women.
  2. Ethnic Group (Non- Arab &/ or Non- Mediterranean)
  3. History of severe allergy or allergic reactions to study drug or related drugs
  4. Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  5. History of serious illness that can impact fate of drugs
  6. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate
  7. Clinically significant illness 4 weeks before study Period I
  8. Mental disease, drug, alcohol, solvents or caffeine abuse, smoking.
  9. Regular use of medication
  10. Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin) during one month before the study initiation.
  11. Presence of any significant physical or organ abnormality
  12. Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
  13. Participation in another bioequivalence study within 80 days prior to the start of this study Period I
  14. Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
  15. History of Gastrointestinal diseases
  16. Prior history of hypersensitivity to Flurbiprofen or Famotidine and other competitive inhibitor of histamine H2-receptors.
  17. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
  18. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  19. Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
  20. Any significant clinical abnormality including HBsAg, HCV, and HIV
  21. Abnormal vital signs
  22. Abnormal Kidney or Liver function tests.
  23. Abnormal Cardiovascular system.
  24. Abnormal Digestive system
  25. Vomiting, Diarrhea.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
FLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once
MULTI-LAYER TABLET
Other Names:
  • MULTI-LAYER TABLET
Active Comparator: ANTADYS® and PEPCID®
ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Other Names:
  • ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cmax
Time Frame: five weeks

Cmax Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine.

AUC Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine.

five weeks
tmax
Time Frame: three weeks
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr. Rana T. Bustami, Ph.D. of Pharmacy, PRU
  • Principal Investigator: Dr. Rana T. Bustami, Ph.D. of Pharmacy, Dr. Rana T. Bustami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 15, 2012

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

December 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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