CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Oxcarbazepine +1 moredrug
Likely dose
Oxcarbazepine 600 mg tablet, single doseAI-extracted
Key inclusion· 5
  • ✓Healthy, non-smoking male and female subjects, 18 years of age or older
  • ✓BMI ≥19 and ≤30
  • ✓Negative for HIV, Hepatitis B/C, drugs of abuse, urine cotinine, and serum HCG (females)
  • ✓No significant diseases or clinically significant findings on physical examination, laboratory values, vital signs, or 12-lead ECG
Key exclusion· 9
  • ✕Known history or presence of any clinically significant medical condition or suspected carcinoma
  • ✕Hypersensitivity or idiosyncratic reaction to oxcarbazepine or similar drug substances
  • ✕Alcoholism within the last 12 months or drug dependence/substance abuse
  • ✕Use of tobacco or nicotine-containing products within the last 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00850174
NCT00850174Phase 1Completed
CompareCT.gov

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 24, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Oxcarbazepine and Trileptal® for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2009
Enrollment StartApr 1, 2005
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago

Interventions

Oxcarbazepinedrug

600 mg Tablet

Trileptal®drug

600 mg Tablet