Healthy
Conditions
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.
Interventions
DRUGCTL0202
Jardiance, tablet, single dose, oral administration
DRUGCTL02
FDC tablet, single dose, oral administration
DRUGCTL0201
Nesina, tablet, single dose, oral administration
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Days to 55 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed