Healthy
Conditions
Brief summary
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
Interventions
DRUGCT-L01 12.5/500 mg
FDC tablet, 2 tablets at a time, oral administration
DRUGAlogliptin Benzoate 12.5 mg
Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration
DRUGMetformin HCl XR 500 mg
Metformin HCl XR 500 mg 2 tablets, at a time, oral administration
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject aged 19 to 50 years, at screening * A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\ 30.0 kg/m2 * A subject 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 within 28 days before the first administration of the investigational drug * A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug * A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.
Exclusion criteria
* A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease * A subject who has an acute illness within 28 days prior to the first dose of investigational drug * A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases * A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration * A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug * A subject who is judged unsuitable to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast (Area under the plasma concentration-time curve) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| Cmax (Peak Plasma Concentration) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf (Area under the plasma concentration-time curve from time 0 to infinity) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| AUClast/AUCinf | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| Tmax (Time of peak plasma concentration) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| t1/2 (Half-life) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
Countries
South Korea
Outcome results
None listed