Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic parameters [One month]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VIVUS, Inc. | Mountain View | California | United States | 94040 |
Sponsors and Collaborators
- VIVUS LLC
Investigators
- Study Director: Wesley W Day, PhD, VIVUS LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OB-102 / AA42851