Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This purpose of this study is to compare the how the body changes the blood level of a single dose of darifenacin when given as 7.5 mg modified release tablet and the modified release liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.

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

Details

• Lead Sponsor: Novartis
• Collaborator: Procter and Gamble
• Treatments: Darifenacin

Criteria

Inclusion Criteria:

• Healthy, male or female subjects age 18 to 50 years of age (inclusive)

• In good health

• Female subjects either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)

• Body mass index within the range of 18.5 to 29.9 kg/m2 and weigh at least 45 kg

Exclusion Criteria:

• Smokers

• History of

• Urinary retention, narrow-angle glaucoma, 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 disorders, 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)

• Known hypersensitivity or severe adverse event to darifenacin or similar drugs

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study

• Immunodeficiency diseases, including a positive HIV (ELISA and 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 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.

• Participation in any clinical investigation within 4 weeks prior to dosing

• Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

• Significant illness within 2 weeks prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply.