Healthy Subjects
Conditions
Brief summary
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
Interventions
DRUGSID1903 (FDC)
Single oral administration of SID1903 (FDC) after an overnight fast
DRUGDapagliflozin and Sitagliptin
Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects aged between 19 years and 55 years(inclusive) * Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2 (inclusive) * Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination * Subjects considered eligible for the study participation in accordance to the results of vital signs, physical examinations, 12-lead ECG, clinical laboratory tests (including hematology, blood chemistry, urinalysis, serology, etc.) and urine drug screening conducted at the time of screening, based on the investigational product (IP) characteristics * Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period
Exclusion criteria
* Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, psychosis disorders, or other medical history * Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries * Pregnant subjects with a positive urine HCG test, or lactating female subjects * Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives containing drug substances or other drugs * Subjects with clinically significant 12-lead ECG findings * Subjects with clinically significant laboratory test results as follows: Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin), Creatinine, eGFR * Subjects with a past history of drug abuse or a positive urine drug test * Subjects with SBP ≥ 140 mmHg or ≤ 90 mmHg; DBP ≥ 90 mmHg or ≤ 60 mmHg; PR ≤ 50 beats/min or ≥ 100 beat/min * Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP * Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals prior to the first IP administration * Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration * Subjects who have consistently drunk alcohol within 6 months * Subjects who have smoked more than 10 cigarettes/day on average * Subjects who have done and are unable to refrain from strenuous activity * Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception * Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t | up to 72 hours |
| Cmax | up to 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 | up to 72 hours |
| CL/F | up to 72 hours |
| Tmax | up to 72 hours |
| λz | up to 72 hours |
| MRT | up to 72 hours |
| Vd/F | up to 72 hours |
| AUCinf | up to 72 hours |
Countries
South Korea
Outcome results
None listed