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Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions

NCT00951600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-08-04

No results posted yet for this study

Summary

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in healthy, adult, male, human subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

oxcarbazepine 300 mg/5mL oral suspension

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-10-31
Completion
2006-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951600 on ClinicalTrials.gov