NCT00866216

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 18, 2009

Last Update Submit

March 27, 2017

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    32 days

Study Arms (2)

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

Azithromycin Monohydrate 600mg Tablets Geneva PharmaceuticalsDRUG
1
Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.DRUG
2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Alan S Marion

    MDS Pharma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 20, 2009

Study Start

August 1, 2003

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

March 29, 2017

Record last verified: 2009-03