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Sponsors and Collaborators: |
Novartis Procter and Gamble |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00413426 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Darifenacin (DAR328) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Bio-availability Study |
Official Title: | 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 |
Estimated Enrollment: | 28 |
Study Start Date: | June 2006 |
Study Completion Date: | September 2007 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CDAR328B2101 |
Study First Received: | December 18, 2006 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00413426 History of Changes |
Health Authority: | India: Ministry of Health |
Pharmacokinetics oral single dose table suspension |
release darifenacin healthy subjects Healthy volunteers study |
Muscarinic Antagonists Neurotransmitter Agents Cholinergic Antagonists |
Darifenacin Healthy Cholinergic Agents |
Muscarinic Antagonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists |
Darifenacin Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |