Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.

Launched by CENTER FOR CLINICAL PHARMACOLOGY RESEARCH BDBEQ S.A. · Oct 22, 2010

Keywords

ClinConnect Summary

Darifenacin is a muscarinic receptor antagonist drug used to treat overactive bladder. There is a new formulation of darifenacin extended release developed by an argentinian pharmaceutical company and, according to regional regulations, a bioequivalence study should be performed to put it in the market.

The purpose of this study is to evaluate the relative bioavailability and pharmacokinetic profiling of a brand generic formulation of darifenacin \[Darisec(R) 15 mg\] vs. the innovator \[Enablex(R) 15 mg\] in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% f...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Healthy male or female subjects 18 to 50 years of age (inclusive)
• • In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician.
• • Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed.
• • Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.
• Exclusion Criteria:
• • Known hypersensitivity or severe adverse event to darifenacin or similar drugs.
• • Urinary retention, narrow-angle glucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon.
• • Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (\>2 days in a week), severe constipation, gastrointestinal obstructive disorder, and gastric retention.
• • Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
• • Acute or chronic bronchospastic disease (including asthma and Chronic Obstructive Pulmonary Disease).
• • Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
• • Smokers of more than 5 cigarettes a week.
• • Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration.
• • Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study.
• • Immunodeficiency diseases, including a positive HIV (Elisa or Western blot) test result.
• • Positive hepatitis B Surface antigen (HBsAg) or Hepatitis C test result.
• • Drug or alcohol abuse within the 6 months prior to dosing.
• • Use of prescription drugs within 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
• • Participation in any clinical investigation within 4 weeks prior to dosing.
• • Donation or loss of 400 ml or more of blood within 2 months prior to dosing.
• • significant illness within 2 weeks prior to dosing.
• • Other protocol-defined inclusion/exclusion criteria may apply.