Status:
COMPLETED
Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Procter and Gamble
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 suspensio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00413426
Start Date
June 1 2006
End Date
September 1 2007
Last Update
April 12 2016
Active Locations (1)
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1
Novartis Investigative Site
Mumbai, India