NCT05082662

Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet

Randomized,Fully-replicated,Single Oral Dose,Open-label,Crossover BE Study to Compare Diclofenac Potassium Coated Tablet (50 mg Diclofenac Potassium) Versus Cataflam® 50 Coated Tablet (50 mg Diclofenac Potassium) in Healthy Subjects in Fasting State

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover, bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) versus Cataflam® 50 coated tablet (50 mg Diclofenac Potassium), in healthy subjects under fasting condition

Conditions

• Non-steroidal Anti-inflammatory (NSAID)
• Analgesic
• Antipyretic

Interventions

Type	Name	Description
DRUG	Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)	One Diclofenac tablet was administered orally.
DRUG	Cataflam® 50 coated tablet	One Diclofenac tablet was administered orally.

Timeline

• Start date: 2020-08-25
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2021-10-19
• Last updated: 2023-12-13

Locations

1 site across 1 country: Jordan