Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
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ClinicalTrials.gov Identifier: NCT00518466 |
Recruitment Status :
Completed
First Posted : August 20, 2007
Last Update Posted : June 8, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: topiramate Drug: phentermine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
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 |
- Pharmacokinetic parameters [ Time Frame: One month ]

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Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518466
United States, California | |
VIVUS, Inc. | |
Mountain View, California, United States, 94040 |
Study Director: | Wesley W Day, PhD | VIVUS, Inc. |
Responsible Party: | Wesley Day, VP Clinical, Vivus, Inc. |
ClinicalTrials.gov Identifier: | NCT00518466 |
Other Study ID Numbers: |
OB-102 / AA42851 |
First Posted: | August 20, 2007 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | June 2011 |
Obesity |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Topiramate Phentermine Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs |
Central Nervous System Stimulants Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |