Status:
COMPLETED
A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05236998
Start Date
November 3 2021
End Date
December 31 2021
Last Update
October 26 2022
Active Locations (1)
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1
Chungbuk National University Hospital
Cheongju-si, South Korea