Comparative Bioavailability Study of 600mg Azithromycin M... | NCT00866216

Studies
Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

NCT00866216

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

38Actual

Phase

Phase 1

Conditions

Infection

Interventions

Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

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

Aug 2003

Primary Completion Date

Sep 2003Actual

Completion Date

Sep 2003Actual

First Submitted Date

Mar 18, 2009

First Submission Date that Met QC Criteria

Mar 19, 2009

First Posted Date

Mar 20, 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

Mar 27, 2017

Last Update Posted Date

Mar 29, 2017Actual

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Azithromycin Monohydrate 600mg Tablets	Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
2	Active Comparator	Zithromax (Azithromycin Dihydrate) 600mg Tablets	Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals	Drug		1
Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		32 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

Positive test results for HIV or hepatitis B or C
Treatment for drug or alcohol dependence
Female subjects who are pregnant or lactating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alan S Marion	MDS Pharma	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017963	Azithromycin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided