A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy Adults

NCT00701493 | Completed Phase 1

• 1 other identifier: CR002239
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to estimate the bioavailability of the oral liquid formulation of topiramate relative to the commercially available oral sprinkle capsule formulation in healthy patients. If appropriate, bioequivalence between the oral liquid formulation and the sprinkle capsule formulation will be assessed.

Conditions

Epilepsy

Keywords

Topiramate; Topiramate oral liquid; TOPAMAX Sprinkle capsule; topiramate capsules

Outcome Measures

Primary Outcomes (1)

• AUClast, AUC¥, and Cmax (Area Under the Curve (last), Area Under the Curve (infinity) and maximum plasma concentration); Incidence, severity, and type of adverse event changes in laboratory results, physical exam, ECG, vital signs.

Interventions

Topiramate oral liquid formulation;Topiramate Sprinkle formulation DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) between 19 and 32 kg/m2, inclusive
• Women of non-child-bearing potential or practicing birth control
• Have a normal electrocardiogram (ECG)
• Be in good health, in the opinion of the investigator
• Be sufficiently alert to understand and communicate intelligibly with the study staff (i.e., patients must be able to perform all study procedures)
• Agree to limit their methylxanthine consumption throughout the study to 2 methylxanthine-containing substances
• Agree to refrain from ingesting products containing grapefruit, quinine, or Seville orange during the study
• Agree to refrain from ingesting antacids during the study
• Agree to refrain from ingesting alcohol during the study
• Have signed an informed consent document indicating that the study has been explained to them and they are willing to participate in the study.

You may not qualify if:

• History of significant renal, hepatic, gastrointestinal, hematologic, pulmonary, metabolic, thyroid, or other chronic disease
• Significant cardiovascular disease, including a history of myocardial infarction within the past 2 years, cerebrovascular accident, clinically significant cardiac valvular disease, unstable angina, significantly abnormal ECG, arrhythmia, or congestive cardiac failure
• History of significant psychiatric disorders including schizophrenia, psychosis, panic disorder, major depression, suicidal attempt or other major affective disorders or current dysthymia. If possible, the investigator shall attempt to confirm the presence or absence of past psychiatric history with subject's primary care physician
• History of raised intraocular pressure, glaucoma, or otherwise at risk for acute narrow-angle glaucoma
• Demonstrate significant active physical disease, acute or chronic, within 7 days before the start of the study
• Liver enzymes (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) outside the normal limits
• Women who wish to become pregnant within 2 months following discontinuation of the study drug, or who are breast-feeding
• Require or have taken any prescription medications within 2 weeks before dosing
• Use of any over-the-counter medications (including aspirin, antacids, vitamins, and herbal supplements (e.g., diuretic tea that may have an impact on renal function) within 7 days before dosing until the end of the study
• Use of hormonal contraceptives (including oral, implanted, intrauterine device, and patch) or hormonal replacement therapy within 3 months before start of screening until 2 months after study completion
• Use of a carbonic anhydrase inhibitor for any reason within 2 weeks before the start of screening
• History of alcohol or drug abuse
• Testing positive for HIV antibody, Hepatitis B antigen, or Hepatitis C antibody
• Abnormal clinical laboratory values, unless reviewed and approved by the Sponsor's medical monitor
• Use of any nicotine-containing products, including tobacco products (e.g., cigarettes, cigars, or chewing tobacco) in the 3 months before start of screening until the end of the study

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• An Open-Label, Randomized, 2-Way Crossover Study of the Bioavailability of an Oral Liquid Formulation Relative to the Marketed Sprinkle Capsule Formulation of Topiramate RWJ-17021-000 in Healthy Subjects

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: November 1, 2004
• Study Completion: December 1, 2004
• Last Updated: June 8, 2011

Record last verified: 2010-03