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

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Darifenacin (DAR328)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413426

CDAR328B2101

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.