NCT05526742

A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects

A Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of a Tablet Formulation of CKD-510 as Compared to Capsule and to Assess the Effect of Food on the CKD 510 Tablet Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the relative bioavailability of CKD-510 tablet formulation compared with CKD-510 capsule formulation, and to characterize the effect of food on the CKD-510 tablet.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CKD-510 capsule (reference)	Single-dose of CKD-510 will be administered as oral capsule in a fasted state.
DRUG	CKD-510 tablet (test)	Single-dose of CKD-510 will be administered as oral tablet in a fasted state.
DRUG	CKD-510 tablet (test)	Single-dose of CKD-510 will be administered as oral tablet in a fed state.

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2022-09-02
• Last updated: 2023-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study