Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Pharmacokinetic parameters [ Time Frame: One month ]
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment 1
One 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. One 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Days 4 - 21 of Period 2. |
Drug: topiramate
25 mg modified-release capsules
Drug: phentermine
7.5 mg immediate-release capsules
|
|
Experimental: treatment 2
Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. One 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsules at Hour 0 on Days 4, 5, and 6 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules (Cardinal) and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2. |
Drug: topiramate
25 mg modified-release capsules
Drug: phentermine
7.5 mg immediate-release capsules
|
|
Experimental: treatment 3
Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsule at Hour 0 on Days 4, 5, and 6 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2. |
Drug: topiramate
25 mg modified-release capsules
Drug: phentermine
7.5 mg immediate-release capsules
|
|
Experimental: treatment 4
Half of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate IR tablet at Hour 0 on Days 1, 2, and 3 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and two 25 mg topiramate IR tablets at Hour 0 on Days 4, 5, and 6 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and three 25 mg topiramate IR tablets at Hour 0 on Days 7, 8, and 9 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Days 10 - 21 of Period 2. |
Drug: topiramate
100 and 25 mg immediate-release tablets
Drug: phentermine
37.5 and 7.5 mg immediate-release tablets
|
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Wesley Day, VP Clinical, Vivus, Inc. |
| ClinicalTrials.gov Identifier: | NCT00518466 History of Changes |
| Other Study ID Numbers: | OB-102 / AA42851 |
| Study First Received: | August 16, 2007 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by VIVUS, Inc.:
|
Obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Phentermine Topiramate Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013