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

NCT07128654 | Completed Phase 1

• 1 other identifier: CT-L02-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCt (Area under the plasma concentration-time curve)

  0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs

• Cmax (Peak Plasma Concentration)

  0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs

Study Arms (2)

Arm A

EXPERIMENTAL

CTL02

Drug: CTL02

Arm B

ACTIVE COMPARATOR

Co-administration of CTL0201 and CTL0202

Drug: CTL0201; Drug: CTL0202

Interventions

CTL02 DRUG

FDC tablet, single dose, oral administration

Arm A

CTL0201 DRUG

Nesina, tablet, single dose, oral administration

Arm B

CTL0202 DRUG

Jardiance, tablet, single dose, oral administration

Arm B

Eligibility Criteria

• Age: 19 Days - 55 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

H+ Yangji Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 19, 2025
• Study Start: September 17, 2025
• Primary Completion: October 5, 2025
• Study Completion: October 26, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

KR (1)