Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VIVUS, Inc.
• Treatments: Phentermine; Topiramate

Criteria

Inclusion Criteria:

• Obese adults

• Body mass index between 30.0 and 42.0 kg/m2 (inclusive)

• Medically healthy with no clinically significant results of screening exams

Exclusion Criteria:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease

• History of glaucoma or increased intraocular pressure

• History of kidney stones

• Cholelithiasis or cholecystitis within 6 months

• Cardiovascular event within 6 months

• Obesity of known genetic or endocrine origin

• Recent weight instability

• Use of Very Low Calorie diet or participation in organized weight loss program within 3 months

• Systolic blood pressure > 150 or diastolic > 95 mm Hg

• Positive urine drug or alcohol screen

• Positive serology for HIV, HBV, or HCV

• History of alcoholism or drug abuse

• History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation

• Hypersensitivity to study drug or related compounds

• Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug

• Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug

• Women who are pregnant or lactating

• Hemoglobin < 12 g/dL

• Use of tobacco or nicotine-containing products within 6 months