Comparative evaluation of the absorption and disposition in the body of a generic formulation of darifenacin 15 mg against the innovator product in healthy fed volunteers.
- Conditions
- Bioequivalence assessment between two formulations of darifenacin 15 mg.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12610000894099
- Lead Sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
Healthy caucasian 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.
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 athma 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) concentration of darifenacin/time (AUC0-t and AUC0-inf). <br>Darifenacin plasma concentration will be measured with Liquid Chromatography-Mass Spectromtry method and concentration vs. time curves will be plotted.<br>AUC0-t will be calculated using the trapezoidal rule.<br>AUC0-inf will be calculated extrapolating the last concentration point to infinity using the log-linear elimination rate constant method.[0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.];Peak concentration (Cmax)<br>Darifenacin plasma concentration will be measured with Liquid Chromatography- Mass Spectrometry Method and concentration vs. time curves will be plotted.<br>Cmax will be taken directly from the darifenacin plasma concentration vs. time curve.[0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.]
- Secondary Outcome Measures
Name Time Method Time to Cmax (tmax).<br>Is the time elapsed from ingestion of darifenacin tablets to plasma peak concentration.[0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.];Absorption Rate Constant(Ka)<br>The absorption rate constant is the fractional rate of drug disappearance from the intestinal tract, measured in the log-linear phase of drug absorption.[0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.];Elimination Rate Constant (Ke)<br>The elimiminaiton rate constant is the fractional rate of drug dissapearance from the peripheral compartment, measured in the log-linear phase of elimination.[0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.]