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Trial record 52 of 1404 for:    Area Under Curve AND tablet

Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT01055769
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : April 5, 2011
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy Volunteers
Intervention Drug: Linezolid
Enrollment 20
Recruitment Details Participants were enrolled at a single site in China.
Pre-assignment Details  
Arm/Group Title Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension
Hide Arm/Group Description Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period). Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
Period Title: First Intervention
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Washout Period of Atleast 4 Days
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Linezolid
Hide Arm/Group Description Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
25.4  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
0
   0.0%
Male
20
 100.0%
1.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Time Frame 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Hide Arm/Group Description:
Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: microgram*hour/milliliter (mcg*h/mL)
108.90  (21.66) 112.00  (24.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid 600 mg Oral Suspension, Linezolid 600 mg Tablet
Comments Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.
Method of Estimation Estimation Parameter Adjusted Geometric Means Ratio
Estimated Value 97.81
Confidence Interval (2-Sided) 90%
93.11 to 102.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.
Time Frame 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Hide Arm/Group Description:
Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: microgram/milliliter (mcg/mL)
15.51  (3.53) 13.68  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid 600 mg Oral Suspension, Linezolid 600 mg Tablet
Comments Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.
Method of Estimation Estimation Parameter Adjusted Geometric Means Ratio
Estimated Value 113.67
Confidence Interval (2-Sided) 90%
105.26 to 122.75
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Hide Description AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time Frame 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Hide Arm/Group Description:
Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
109.20  (21.72) 112.60  (24.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid 600 mg Oral Suspension, Linezolid 600 mg Tablet
Comments Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.
Method of Estimation Estimation Parameter Adjusted Geometric means ratio
Estimated Value 97.65
Confidence Interval (2-Sided) 90%
92.92 to 102.63
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description The time of the first occurrence of peak concentration observed directly from data.
Time Frame 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600mg Tablet
Hide Arm/Group Description:
Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: hours
0.63
(0.50 to 2.00)
1.50
(0.50 to 4.00)
5.Secondary Outcome
Title Terminal Half-Life (t1/2)
Hide Description Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Hide Arm/Group Description:
Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: hours
5.08  (0.70) 5.13  (0.92)
Time Frame Baseline to Day 3
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Hide Arm/Group Description Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight. Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
All-Cause Mortality
Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linezolid 600 mg Oral Suspension Linezolid 600 mg Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/20 (5.00%)    
Gastrointestinal disorders     
Abdominal Pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055769     History of Changes
Other Study ID Numbers: A5951152
First Submitted: January 22, 2010
First Posted: January 26, 2010
Results First Submitted: March 4, 2011
Results First Posted: April 5, 2011
Last Update Posted: February 1, 2012