Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects
This study has been completed.
Procter and Gamble
Information provided by:
First received: December 18, 2006
Last updated: November 29, 2007
Last verified: November 2007
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.
Drug: Darifenacin (DAR328)
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Labeled, Randomized, Single Dose, Three Period, 2-Sequence Crossover Study to Investigate the Pharmacokinetics of Darifenacin When Given as 7.5 mg Oral Doses of a Modified Release Suspension, as Compared to the Commercial Modified Release Tablet in Healthy Adult
Primary Outcome Measures:
- Comparison of the PK of a single dose of 7.5 reference modified release tablet of darifenacin and the tested modified release liquid suspension (1.5 mg/ml) of darifenacin under fasted conditions in healthy subjects
- Comparison of the PK of a single dose of darifenacin when given as an oral dose of a 7.5 mg modified release liquid suspension in the fed and fasted states
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413426
|Novartis Investigative Site
|Mumbai, India |
Procter and Gamble
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 18, 2006
||November 29, 2007
||India: Ministry of Health
Keywords provided by Novartis:
Healthy volunteers study
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs