A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of SID1903 (Fixed-dose Combination of Dapagliflozin and Sitagliptin) or Loose Combination in Healthy Adult Volunteers

SK Chemicals Co., Ltd.1 site in 1 country45 target enrollmentNovember 3, 2021

ConditionsHealthy Subjects

InterventionsSID1903 (FDC)Dapagliflozin and Sitagliptin

Overview

Phase: Phase 1
Intervention: SID1903 (FDC)
Conditions: Healthy Subjects
Sponsor: SK Chemicals Co., Ltd.
Enrollment: 45
Locations: 1
Primary Endpoint: AUC0-t
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 3, 2021

End Date

December 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

SK Chemicals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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