A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
Not Applicable
Recruiting
- Conditions
- Healthy
- Interventions
- Drug: CTL02Drug: CTL0201Drug: 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
Group Intervention Description Arm A CTL02 CTL02 Arm B CTL0201 Co-administration of CTL0201 and CTL0202 Arm B CTL0202 Co-administration of CTL0201 and CTL0202
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (1)
H+ Yangji Hospital
🇰🇷Seoul, Korea, Republic of
H+ Yangji Hospital🇰🇷Seoul, Korea, Republic ofPrincipal InvestigatorContact+82-1877-8875