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

NCT05002244 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2021-08-29
Completion
2021-09-13

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002244 on ClinicalTrials.gov