At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Linezolid +1 moredrug
Likely dose
Linezolid 600 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Single Dose, 2-Way, Randomized Cross-Over Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Linezolid for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartMar 2010
Primary CompletionApr 2010
TodayJul 2026
First PostedJan 26, 2010
Enrollment StartMar 1, 2010
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.4 years ago
Interventions
Linezoliddrug
1. Linezolid OS 600 MG 2. Linezolid Tablet 600 MG
Linezoliddrug
1. Linezolid Tablet 600 MG 2. Linezolid OS 600 MG