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

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

Not Recruiting
19-55 years
All
Phase 1

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Overview

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.

Eligibility

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

Study details
    Healthy

NCT07128654

Celltrion

12 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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