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

NCT05307614 | Completed Phase 1

• 2 other identifiers: MOXI1001CB-023-MOX-2017/Protocol/2.0
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioequivalence

Keywords

Moxifloxacin; Fluoroquinolone; Bioequivalence; Pakistani population

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Tmax

  0-72 hours post dose

Study Arms (2)

Moksi® 400mg Tablet of Abbott

EXPERIMENTAL

Healthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition

Drug: Moksi® 400mg Tablet; Drug: Drug: Avelox® 400Mg Tablet

Avelox® 400mg Tablet of Bayer

ACTIVE COMPARATOR

Healthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition.

Drug: Moksi® 400mg Tablet; Drug: Drug: Avelox® 400Mg Tablet

Interventions

Moksi® 400mg Tablet DRUG

Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.

Also known as: Moksi®

Avelox® 400mg Tablet of Bayer; Moksi® 400mg Tablet of Abbott

Drug: Avelox® 400Mg Tablet DRUG

Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.

Also known as: Avelox®

Avelox® 400mg Tablet of Bayer; Moksi® 400mg Tablet of Abbott

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Tablets; Moxifloxacin

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Raeefuddin Ahmed, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross Over

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 1, 2022
• Study Start: March 27, 2019
• Primary Completion: April 23, 2019
• Study Completion: April 27, 2019
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

PA (1)