A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers

NCT ID: NCT07128654

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-17

Study Completion Date

2025-10-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

CTL02

Group Type EXPERIMENTAL

CTL02

Intervention Type DRUG

FDC tablet, single dose, oral administration

Arm B

Co-administration of CTL0201 and CTL0202

Group Type ACTIVE_COMPARATOR

CTL0201

Intervention Type DRUG

Nesina, tablet, single dose, oral administration

CTL0202

Intervention Type DRUG

Jardiance, tablet, single dose, oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CTL02

FDC tablet, single dose, oral administration

Intervention Type DRUG

CTL0201

Nesina, tablet, single dose, oral administration

Intervention Type DRUG

CTL0202

Jardiance, tablet, single dose, oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy participant aged 19 to 55 years, at screening
* A participant who has a body mass index (BMI) of 18.0\~29.9 kg/m2, at screening
* A participant who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator

Exclusion Criteria

* A participant who has taken drugs that induce or inhibit drug metabolizing enzymes
* A participant who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
* A participant who has a history of gastrointestinal surgery that may affect drug absorption
Minimum Eligible Age

19 Days

Maximum Eligible Age

55 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

H+ Yangji Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT-L02-102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bioequivalence Study of CJ-30059
NCT02173912 UNKNOWN PHASE1
Bioequivalence Study in Healthy Subjects
NCT00844324 COMPLETED PHASE1