NCT03574285

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

Detailed description

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anpl-one SR Tab. 300mg	Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
DRUG	Sarpodipil SR Tab. 300mg	Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Timeline

• Start date: 2018-05-31
• Primary completion: 2018-08-21
• Completion: 2018-10-12
• First posted: 2018-06-29
• Last updated: 2019-05-13

Locations

1 site across 1 country: South Korea