Trial Outcomes & Findings for Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects (NCT NCT01055769)

NCT ID: NCT01055769

Last Updated: 2012-02-01

Results Overview

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Results posted on

2012-02-01

Participant Flow

Participants were enrolled at a single site in China.

Participant milestones

Participant milestones
Measure	Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet 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 600 mg Tablet, Then Linezolid 600 mg Oral Suspension 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).
First Intervention STARTED	10	10
First Intervention COMPLETED	10	10
First Intervention NOT COMPLETED	0	0
Washout Period of Atleast 4 Days STARTED	10	10
Washout Period of Atleast 4 Days COMPLETED	10	10
Washout Period of Atleast 4 Days NOT COMPLETED	0	0
Second Intervention STARTED	10	10
Second Intervention COMPLETED	10	10
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Linezolid n=20 Participants Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Age Continuous	25.4 Years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Population: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

Outcome measures

Outcome measures
Measure	Linezolid 600 mg Oral Suspension n=20 Participants Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 Participants Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	108.90 microgramhour/milliliter (mcgh/mL) Standard Deviation 21.66	112.00 microgramhour/milliliter (mcgh/mL) Standard Deviation 24.74

PRIMARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Population: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.

Outcome measures

Outcome measures
Measure	Linezolid 600 mg Oral Suspension n=20 Participants Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 Participants Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Maximum Observed Plasma Concentration (Cmax)	15.51 microgram/milliliter (mcg/mL) Standard Deviation 3.53	13.68 microgram/milliliter (mcg/mL) Standard Deviation 3.53

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Population: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

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-∞).

Outcome measures

Outcome measures
Measure	Linezolid 600 mg Oral Suspension n=20 Participants Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 Participants Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	109.20 mcg*h/mL Standard Deviation 21.72	112.60 mcg*h/mL Standard Deviation 24.94

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Population: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

The time of the first occurrence of peak concentration observed directly from data.

Outcome measures

Outcome measures
Measure	Linezolid 600 mg Oral Suspension n=20 Participants Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 Participants Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0.63 hours Interval 0.5 to 2.0	1.50 hours Interval 0.5 to 4.0

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Population: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Linezolid 600 mg Oral Suspension n=20 Participants Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 Participants Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Terminal Half-Life (t1/2)	5.08 hours Standard Deviation 0.70	5.13 hours Standard Deviation 0.92

Adverse Events

Linezolid 600 mg Oral Suspension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Linezolid 600 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Linezolid 600 mg Oral Suspension n=20 participants at risk Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.	Linezolid 600 mg Tablet n=20 participants at risk Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
Gastrointestinal disorders Abdominal Pain	0.00% 0/20 • Baseline to Day 3 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.	5.0% 1/20 • Number of events 1 • Baseline to Day 3 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER