A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT05236998
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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/exclusion criteria at the investigator's discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence B Dapagliflozin and Sitagliptin Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin Sequence A Dapagliflozin and Sitagliptin Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC) Sequence B SID1903 (FDC) Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin Sequence A SID1903 (FDC) Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC)
- Primary Outcome Measures
Name Time Method AUC0-t up to 72 hours Cmax up to 72 hours
- Secondary Outcome Measures
Name Time Method Vd/F up to 72 hours AUCinf up to 72 hours λz up to 72 hours MRT up to 72 hours Tmax up to 72 hours t1/2 up to 72 hours CL/F up to 72 hours
Trial Locations
- Locations (1)
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Chungbuk National University Hospital🇰🇷Cheongju-si, Korea, Republic of