A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00830206

Recruitment Status : Completed

First Posted : January 27, 2009

Results First Posted : July 21, 2009

Last Update Posted : September 11, 2009

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
Condition:	Healthy
Interventions:	Other: Azithromycin Drug: Zithromax®

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Azithromycin (Test) First	Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
Zithromax® (Reference) First	Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period

Participant Flow for 3 periods

Period 1: First Intervention

	Azithromycin (Test) First	Zithromax® (Reference) First
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Period 2: Washout: 21 Days

	Azithromycin (Test) First	Zithromax® (Reference) First
STARTED	40	40
COMPLETED	39	39
NOT COMPLETED	1	1
Withdrawal by Subject	1	1

Period 3: Second Intervention

	Azithromycin (Test) First	Zithromax® (Reference) First
STARTED	39	39
COMPLETED	39	39
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Azithromycin (Test) First	Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
Zithromax® (Reference) First	Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
Total	Total of all reporting groups

Baseline Measures

	Azithromycin (Test) First	Zithromax® (Reference) First	Total
Overall Participants Analyzed [Units: Participants]	40	40	80

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	39	40	79
>=65 years	1	0	1

Gender [Units: Participants]
Female	18	22	40
Male	22	18	40

Race/Ethnicity, Customized [Units: Participants]
White	38	35	73
Black	2	2	4
Asian	0	1	1
Native American	0	2	2

Region of Enrollment [Units: Participants]
United States	40	40	80

Outcome Measures

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1. Primary:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 168 hour period ]

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2. Primary:

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 168 hour period ]

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3. Primary:

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 168 hour period ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Principal Investigator is not permitted to discuss or publish trial results.

Results Point of Contact:

Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com

Responsible Party:	Vice President Global Generic Biopharmaceutics, TEVA Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00830206 History of Changes
Other Study ID Numbers:	R05-1430
First Submitted:	January 26, 2009
First Posted:	January 27, 2009
Results First Submitted:	June 18, 2009
Results First Posted:	July 21, 2009
Last Update Posted:	September 11, 2009

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