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A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers

NCT05364164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-01-12

No results posted yet for this study

Summary

This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

CT-L01 12.5/1,000 mg

FDC tablet, 2 tablets at a time, oral administration, dosing under fasting condition

DRUG

CT-L01 12.5/1,000 mg

FDC tablet, 2 tablets at a time, oral administration, dosing after high-fat meal

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-07-09
Primary Completion
2022-07-19
Completion
2022-07-25

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 NCT05364164 on ClinicalTrials.gov