Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
Information source: VIVUS, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: topiramate (Drug); phentermine (Drug); topiramate (Drug); phentermine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: VIVUS, Inc. Official(s) and/or principal investigator(s):
Charles H Bowden, MD, Study Director, Affiliation: VIVUS, Inc.
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Pharmacokinetic parameters
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
VIVUS, Inc., Mountain View, California 94040, United States
Additional Information
Starting date: July 2007
Ending date: December 2007
Last updated: April 2, 2008
|
