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A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

NCT05363592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-01-12

No results posted yet for this study

Summary

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

CT-L01 12.5/500 mg

FDC tablet, 2 tablets at a time, oral administration

DRUG

Alogliptin Benzoate 12.5 mg

Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration

DRUG

Metformin HCl XR 500 mg

Metformin HCl XR 500 mg 2 tablets, at a time, oral administration

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
2022-06-25
Primary Completion
2022-07-05
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 NCT05363592 on ClinicalTrials.gov