NCT05002244

A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers

A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.

Conditions

• Health, Subjective

Interventions

Type	Name	Description
DRUG	CTL0801 (Azilsartan)	CTL0801 (Azilsartan), single dose, daily, repeated oral administration
DRUG	CTL0802 (Rosuvastatin)	CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration
DRUG	CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)	CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration

Timeline

• Start date: 2021-07-23
• Primary completion: 2021-08-29
• Completion: 2021-09-13
• First posted: 2021-08-12
• Last updated: 2021-12-23

Locations

1 site across 1 country: South Korea