Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MDS Pharina Services (Clinical Research Center)

Saint Laurent, Québec, H4R 2N6, Canada

About this study

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates. All 28 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.

Exclusion criteria

History or presence of significant:

cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

Hypersensitivity or idiosyncratic reaction to topiramate
Nephrolithiasis or gout
Alcoholism or drug abuse within the past year
Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
Subjects who had any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
Subjects who, through completion of the study, would have donated in excess of:

500 mL of blood in 14 days, or
500-750 mL of blood in 14 days (unless approved by the Principal Investigator),
1000 mL of blood in 90 days,
1250 mL of blood in 120 days,
1500 mL of blood in 180 days,
2000 mL of blood in 270 days,
2500 mL of blood in 1 year,
Subjects who had participated in another clinical trial within 28 days of study start.

Treatment and study plan

Topiramate

Drug

25mg Tablets

Primary outcomes

Bioequivalence evaluation of Topiramate 25mg tablets

Sponsors and collaborators

Lead sponsor

Ranbaxy Laboratories Limited

Industry

Registry information

Official study title

Comparative, Randomized, Single Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg Topiramate Tablets Following a 50 mg Dose in Healthy Adult Males Under Fasting Conditions

Important dates

Study start: 2001
Primary completion: 2001
Study completion: 2001
First posted: May 14, 2009
Registry last updated: Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed