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

NCT ID: NCT00413426

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-09-30

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Darifenacin (DAR328)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

Mumbai, , India

Countries

India

Other Identifiers

CDAR328B2101

Identifier Type: -

Identifier Source: org_study_id