An Open Label, Randomized, Crossover Study To Estimate Th... | NCT00879983

Studies
An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

NCT00879983

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jun 14, 2010Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

azithromycin (Zithromax)
azithromycin (Zithromax)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

Official Title

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Apr 10, 2009

First Submission Date that Met QC Criteria

Apr 10, 2009

First Posted Date

Apr 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2010

Last Update Posted Date

Jun 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Other	Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.	Drug: azithromycin (Zithromax)
Group 2	Other	Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .	Drug: azithromycin (Zithromax)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
azithromycin (Zithromax)	Drug	a single dose of azithromycin ER 2g 3-day regimen of azithromycin tablet 500mg	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC inf (if data permit) and AUC last of azithromycin		2 months

Secondary Outcomes

Measure	Description	Time Frame
AUC 24, Cmax, Tmax, t1/2 of azithromycin		2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers.
Male.
18-45 years old.
BMI 17.5-30.5 kg/m2.

Exclusion Criteria:

Alcohol, drug, smoke user.
Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
Severe medical or psychiatric condition or laboratory abnormality.
Blood donation.
12-ECG abnormal.
Treatment with study drug; clinically significant.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Shanghai		200040	China

References Module

Citations

Not provided

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals