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

NCT ID: NCT01910090

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-01-31

Brief 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.

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

FLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once

Group Type: EXPERIMENTAL

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

Intervention Type: DRUG

MULTI-LAYER TABLET

ANTADYS® and PEPCID®

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

Group Type: ACTIVE_COMPARATOR

ANTADYS® 100 mg, PEPCID® 20 mg

Intervention Type: DRUG

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

Interventions

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

MULTI-LAYER TABLET

Intervention Type: DRUG

ANTADYS® 100 mg, PEPCID® 20 mg

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

Intervention Type: DRUG

Other Intervention Names

MULTI-LAYER TABLET; ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmaceutical Research Unit, Jordan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

PRU

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

Role: PRINCIPAL_INVESTIGATOR

Dr. Rana T. Bustami

Locations

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Amman, , Jordan

Countries

Jordan

Other Identifiers

FAFL439/PRO-00

Identifier Type: -

Identifier Source: org_study_id