NCT05307614

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Abbott · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Moksi® 400mg Tablet	Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
DRUG	Drug: Avelox® 400Mg Tablet	Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.

Timeline

• Start date: 2019-03-27
• Primary completion: 2019-04-23
• Completion: 2019-04-27
• First posted: 2022-04-01
• Last updated: 2022-04-01

Locations

1 site across 1 country: Pakistan