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

Not Applicable
Recruiting
Conditions
Healthy
Interventions
Drug: CTL02
Drug: CTL0201
Drug: CTL0202
Registration Number
NCT07128654
Lead Sponsor
Celltrion
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Arm ACTL02CTL02
Arm BCTL0201Co-administration of CTL0201 and CTL0202
Arm BCTL0202Co-administration of CTL0201 and CTL0202
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

H+ Yangji Hospital

🇰🇷

Seoul, Korea, Republic of

H+ Yangji Hospital
🇰🇷Seoul, Korea, Republic of
Principal Investigator
Contact
+82-1877-8875

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