Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects

Study Overview
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Brief Summary
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Single dose, two way crossover Bioequivalence (BE) study to evaluate the comparative bioavailability of moxifloxacin.

Detailed Description
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A single center, single-dose, open-label randomized , 2-way crossover Bioequivalence study in healthy Pakistani subjects. Study drugs, Moksi® 400 mg (Moxifloxacin) Tablet manufactured by Abbot Laboratories (Pakistan) Limited and Avelox® 400mg (Moxifloxacin) Tablet manufactured by Bayer HealthCare Pharmaceuticals Inc were administered in two periods separated by a washout period of seven (07) days. After dosing, serial blood samples were collected for a period of 72.0 hours.

Official Title
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A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Relative Bioavailability of Moksi 400mg (Moxifloxacin) Tablet and Avelox 400mg (Moxifloxacin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Moksi® 400mg Tablet
* Drug: Drug: Avelox® 400Mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 18 to 55 years inclusive. Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive). Subjects who are healthy as determined by routine physical examination,including vital sign monitoring (ie, blood pressure, heart rate,and temperature), 12 lead ECG ,chest X ray and laboratory analysis (ie, hematology, blood biochemistry and urinalysis), as determined by the investigator. Subjects should have negative urine test for drugs of abuse (Opiates, benzodiazepines, amphetamines, barbiturates, cannabinoids and cocaine will be tested) and alcohol breath analysis at screening and prior to each check-in. Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra- uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug All subjects should be free from any epidemic or contagious diseases (e.g. Malaria, Dengue). Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day. Exclusion Criteria: History of smoking (> 5 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication. Subject is allergic to Moxifloxacin and/or other fluoroquinolones Subject has received any investigational drug within four weeks. Subjects with known prolongation of the QT interval. Subjects receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents. Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood) Subject taking any vitamins or herbal supplements during within last 14 days of drug administration. Donation or loss of more than 450 mL of blood within 3 months prior to the screening. Ingestion of OTC drug, within 7 days of drug administration (e.g. aspirin, ibuprofen). History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study. History of any significant illness in the last four weeks Subjects who smoke and/or take nicotine in any form. Non-smoking subjects, who have previously smoked, should at least be non-smoking for 6 months prior to dosing. Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, verapamil and dronedarone. Consumption of grapefruit and/or its products within 14 days prior to the start of study. Subjects who test positive for syphilis (VDRL)or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2) Individuals having undergone any major surgery within 3 months prior to the start of the study, Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating moxifloxacin to the subject. Inability to take oral medication. Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs. Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross Over
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moksi® 400mg Tablet of Abbott<br>Healthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition | Drug: Moksi® 400mg Tablet<br>* Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.<br>* Other names: Moksi®;Drug: Drug: Avelox® 400Mg Tablet<br>* Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.<br>* Other names: Avelox®;|
| Active Comparator: Avelox® 400mg Tablet of Bayer<br>Healthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition. | Drug: Moksi® 400mg Tablet<br>* Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.<br>* Other names: Moksi®;Drug: Drug: Avelox® 400Mg Tablet<br>* Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.<br>* Other names: Avelox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum plasma concentration of Moxifloxacin | 0-72 hours post dose | 
| AUC last (AUC 0-t) | Area under plasma concentration time curve from zero to time of the last measurable concentration | 0-72 hours post dose | 
| AUC total (AUC 0-∞) | area under the plasma concentration-time curve from zero to infinity. | 0-72 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | time to reach maximum plasma concentration | 0-72 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moxifloxacin, Fluoroquinolone, Bioequivalence, Pakistani population