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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: azithromycin (Zithromax)
* Drug: azithromycin (Zithromax)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet. | Drug: azithromycin (Zithromax)<br>* a single dose of azithromycin ER 2g 3-day regimen of azithromycin tablet 500mg<br>* Other names: Zithromax;|
| Other: Group 2<br>Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER . | Drug: azithromycin (Zithromax)<br>* 3-day regimen of azithromycin tablet 500mg a single dose of azithromycin ER 2g<br>* Other names: Zithromax;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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azithromycin, pharmacokinetics