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

NCT01910090 | Completed Phase 1

• 1 other identifier: FAFL439/PRO-00
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

fasting condition

Outcome Measures

Primary Outcomes (2)

• cmax

  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

  three weeks

Study Arms (2)

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

EXPERIMENTAL

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

Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

ANTADYS® and PEPCID®

ACTIVE COMPARATOR

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

Drug: ANTADYS® 100 mg, PEPCID® 20 mg

Interventions

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET DRUG

MULTI-LAYER TABLET

Also known as: MULTI-LAYER TABLET

FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET

ANTADYS® 100 mg, PEPCID® 20 mg DRUG

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

Also known as: ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

ANTADYS® and PEPCID®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Women.
• Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
• History of severe allergy or allergic reactions to study drug or related drugs
• Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
• History of serious illness that can impact fate of drugs
• 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
• Clinically significant illness 4 weeks before study Period I
• Mental disease, drug, alcohol, solvents or caffeine abuse, smoking.
• Regular use of medication
• 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.
• Presence of any significant physical or organ abnormality
• 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
• Participation in another bioequivalence study within 80 days prior to the start of this study Period I
• Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
• History of Gastrointestinal diseases

Sponsors & Collaborators

• Pharmaceutical Research Unit, Jordan: lead

Study Sites (1)

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Amman, 00962, Jordan

Location

MeSH Terms

Interventions

Flurbiprofen; Famotidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

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

  PRU

  PRINCIPAL INVESTIGATOR

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

  Dr. Rana T. Bustami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2012
• First Posted: July 29, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2012-12

Locations

JO (1)