- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01910090
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
Status
Completed
Conditions
Intervention / Treatment
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:
- 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.
Exclusion Criteria:
- 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
- Prior history of hypersensitivity to Flurbiprofen or Famotidine and other competitive inhibitor of histamine H2-receptors.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- Any significant clinical abnormality including HBsAg, HCV, and HIV
- Abnormal vital signs
- Abnormal Kidney or Liver function tests.
- Abnormal Cardiovascular system.
- Abnormal Digestive system
- 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:
|
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:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Famotidine
- Flurbiprofen
Other Study ID Numbers
- FAFL439/PRO-00
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
-
Chong Kun Dang PharmaceuticalCompletedDyslipidemiasKorea, Republic of
-
BayerCompletedPharmacokineticsGermany
-
GlaxoSmithKlinePiramal Clinical Research (Hyderabad, India)Completed
-
GlaxoSmithKlinePiramal Clinical Research (Hyderabad, India)Completed
-
Cassava Sciences, Inc.National Institute on Aging (NIA)Completed
-
Eisai Co., Ltd.Completed
-
Vanda PharmaceuticalsCompleted
-
University of Erlangen-Nürnberg Medical SchoolBayerRecruiting
-
Kirby InstituteRecruitingHepatitis C | Liver Cirrhoses | Liver InflammationAustralia