We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518466
First Posted: August 20, 2007
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VIVUS, Inc.
  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
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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

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


Locations
United States, California
VIVUS, Inc.
Mountain View, California, United States, 94040
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Wesley W Day, PhD VIVUS, Inc.
  More Information

Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT00518466     History of Changes
Other Study ID Numbers: OB-102 / AA42851
First Submitted: August 16, 2007
First Posted: August 20, 2007
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by VIVUS, Inc.:
Obesity

Additional relevant MeSH terms:
Topiramate
Phentermine
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Central Nervous System Stimulants
Appetite Depressants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action