Healthy VolunteersPhase 1NCT01055769

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

A Phase 1 study testing Linezolid in people with Healthy Volunteers, run by Pfizer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Linezolid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: Mar 2010to Apr 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers.
18-40 years old, male.
BMI 19-24kg/m2.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Pfizer Investigational Site
Shanghai, 200040

Other trials in China

About this study

Official title: 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

Read the detailed description

To support Linezolid NDA in China.

Conditions: Healthy Volunteers
Being tested: Linezolid
Keywords: Bio-equivalence, Linezolid OS, Linezolid tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LinezolidDrug
Also called Zyvox
1. Linezolid OS 600 MG
2. Linezolid Tablet 600 MG
LinezolidDrug
Also called Zyvox
1. Linezolid Tablet 600 MG
2. Linezolid OS 600 MG

Study groups in NCT01055769
Study group	Role	What they receive
Group 1	Other	Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG. Receives: Drug: Linezolid
Group 2	Other	Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG. Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary outcomes (3)

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
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-∞).
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The time of the first occurrence of peak concentration observed directly from data.
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Terminal Half-Life (t1/2)
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Apr 2010

First posted26 Jan 2010 (estimated)
Study startMar 2010
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01055769
Sponsor's protocol ID: A5951152
Status last verified: Jan 2012
First submitted: 22 Jan 2010
Last updated: 1 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01055769
Acronym / sponsor ID: A5951152
Conditions: Healthy Volunteers
Keywords: Bio-equivalence, Linezolid OS, Linezolid tablet
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 26 Jan 2010 (estimated)
Results: Posted 5 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To support Linezolid NDA in China.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Other	Drug: LinezolidSubjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.
Group 2	Other	Drug: LinezolidSubjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy volunteers.
18-40 years old, male.
BMI 19-24kg/m2.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LinezolidAlso: Zyvox1. Linezolid OS 600 MG 2. Linezolid Tablet 600 MG	Drug	Group 1
LinezolidAlso: Zyvox1. Linezolid Tablet 600 MG 2. Linezolid OS 600 MG	Drug	Group 2

Primary outcome

Area Under the Curve From Time Zero to Last Quantifiable 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
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.

3 secondary outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Terminal Half-Life (t1/2)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Results and safety

Results posted to the registry on 5 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet	10	10
Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension	10	10

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable 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. Mean (Standard Deviation). Unit: microgram*hour/milliliter (mcg*h/mL)

Measure	Linezolid 600 mg Oral Suspension n = 20	Linezolid 600 mg Tablet n = 20
Value	108.90 (21.66)	112.00 (24.74)

Linezolid 600 mg Oral Suspension vs Linezolid 600 mg Tablet: Adjusted Geometric Means Ratio: 97.81 (90% CI 93.11 to 102.75)

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

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose. Mean (Standard Deviation). Unit: microgram/milliliter (mcg/mL)

Measure	Linezolid 600 mg Oral Suspension n = 20	Linezolid 600 mg Tablet n = 20
Value	15.51 (3.53)	13.68 (3.53)

Linezolid 600 mg Oral Suspension vs Linezolid 600 mg Tablet: Adjusted Geometric Means Ratio: 113.67 (90% CI 105.26 to 122.75)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Day 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linezolid 600 mg Oral Suspension	0 of 20 (0%)	0 of 20 (0%)	Not reported
Linezolid 600 mg Tablet	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Linezolid in people with Healthy Volunteers, run by Pfizer at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to Last Quantifiable 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01055769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.