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Sponsored by: |
VIVUS, Inc. |
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Information provided by: | VIVUS, Inc. |
ClinicalTrials.gov Identifier: | NCT00518466 |
The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: topiramate Drug: phentermine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults |
Estimated Enrollment: | 64 |
Study Start Date: | July 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | OB-102 / AA42851 |
Study First Received: | August 16, 2007 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00518466 |
Health Authority: | United States: Food and Drug Administration |
Obesity |
Body Weight Signs and Symptoms Obesity Topiramate |
Nutrition Disorders Overweight Overnutrition Phentermine |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents Neuroprotective Agents |
Pharmacologic Actions Anti-Obesity Agents Autonomic Agents Therapeutic Uses Appetite Depressants Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |