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

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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 volunteers after a high fat breakfast.

The bioequivalence will be evaluated using:

• the Area Under the Curve (AUC) and,

• the peak plasma concentration (Cmax).

Safety will be evaluated recording:

• vital signs

• adverse events,

• laboratory analysis.

• EKG and chest XRays.

Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:

• mean AUCt/AUCr and 90% confidence interval within 0.80-1.25

• mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A.
• Collaborators: Laboratorio Elea Phoenix S.A.; Laboratorio Elea S.A.C.I.F. y A.
• Treatments: Cholinergic Agents; Cholinergic Antagonists; Darifenacin; Muscarinic Antagonists

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.