Phase 1
Completed N=20
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT01055769 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 108.90; 112.00 microgram*hour/milliliter (mcg*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
108.90; 112.00 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
15.51; 13.68 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
109.20; 112.60 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.63; 1.50 | — |
| SECONDARY Terminal Half-Life (t1/2) |
5.08; 5.13 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers.
- 18-40 years old, male.
- BMI 19-24kg/m2.
Exclusion Criteria
- Alcohol, drug, smoke user.
- Sensitive to oxazolidinones antibiotics class drug or heparin.
- Severe medical or psychiatric condition or laboratory abnormality.
- Blood donation.
- 12-ECG abnormal.
- Treatment with study drug; clinically significant.
Data sourced from ClinicalTrials.gov (NCT01055769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.