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Trial record 3 of 69 for:    Famotidine

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

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ClinicalTrials.gov Identifier: NCT01910090
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
Pharmaceutical Research Unit, Jordan

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET Drug: ANTADYS® 100 mg, PEPCID® 20 mg Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : December 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
FLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once
Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
MULTI-LAYER TABLET
Other Name: MULTI-LAYER TABLET

Active Comparator: ANTADYS® and PEPCID®
ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Drug: ANTADYS® 100 mg, PEPCID® 20 mg
ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Other Name: ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once




Primary Outcome Measures :
  1. 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.


  2. tmax [ Time Frame: three weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910090


Locations
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Jordan
Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit
Amman, Jordan, 00962
Sponsors and Collaborators
Pharmaceutical Research Unit, Jordan
Investigators
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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

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Responsible Party: Pharmaceutical Research Unit, Jordan
ClinicalTrials.gov Identifier: NCT01910090     History of Changes
Other Study ID Numbers: FAFL439/PRO-00
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: December 2012

Keywords provided by Pharmaceutical Research Unit, Jordan:
fasting condition

Additional relevant MeSH terms:
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Famotidine
Flurbiprofen
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors