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Completed

NCT Number: NCT07128654

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

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.

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Key information

Conditions

Healthy

Age range

19 day–55 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H+ Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTL02

Drug

FDC tablet, single dose, oral administration

CTL0201

Drug

Nesina, tablet, single dose, oral administration

CTL0202

Drug

Jardiance, tablet, single dose, oral administration

Primary outcomes

  1. AUCt (Area under the plasma concentration-time curve)

    Time frame: 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

  2. Cmax (Peak Plasma Concentration)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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