Status:
UNKNOWN
Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.
Lead Sponsor:
Center for Clinical Pharmacology Research Bdbeq S.A.
Collaborating Sponsors:
Laboratorio Elea Phoenix S.A.
Conditions:
Bioequivalency
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The present study was designed to assess the bioequivalence and pharmacokinetic profiling of a brand generic formulation of darifenacin \[Darisec(R)\]vs. the innovator \[Enablex(R)\]in healthy volunte...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01227811
Start Date
November 1 2010
End Date
March 1 2011
Last Update
October 25 2010
Active Locations (1)
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1
Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano de Montevideo..
Montevideo, Montevideo Department, Uruguay, 11600