Overview

A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
SK Chemicals Co., Ltd.
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

- 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