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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
* Drug: ANTADYS® 100 mg, PEPCID® 20 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention 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<br>FLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once | Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET<br>* MULTI-LAYER TABLET<br>* Other names: MULTI-LAYER TABLET;|
| Active Comparator: ANTADYS® and PEPCID®<br>ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once | Drug: ANTADYS® 100 mg, PEPCID® 20 mg<br>* ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once<br>* Other names: ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting condition