NCT04156685

Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1

An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387

Detailed description

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Part A, Reference (D635 10/500mg, Astrazeneca)	Once a day. Under fasting condition
DRUG	Part A, Reference (D635 10/500mg, Astrazeneca)	Once a day. Under fasting condition
DRUG	Part B, Reference (D635 10/500mg, Astrazeneca)	Once a day. Under fed condition
DRUG	Part B, Reference (D635 10/500mg, Astrazeneca)	Once a day. Under fed condition

Timeline

• Start date: 2019-08-06
• Primary completion: 2019-08-30
• Completion: 2019-10-02
• First posted: 2019-11-07
• Last updated: 2019-11-07

Locations

1 site across 1 country: South Korea