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

NCT ID: NCT05236998

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2021-12-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A

Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC)

Group Type: EXPERIMENTAL

SID1903 (FDC)

Intervention Type: DRUG

Single oral administration of SID1903 (FDC) after an overnight fast

Dapagliflozin and Sitagliptin

Intervention Type: DRUG

Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Sequence B

Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin

Group Type: EXPERIMENTAL

SID1903 (FDC)

Intervention Type: DRUG

Single oral administration of SID1903 (FDC) after an overnight fast

Dapagliflozin and Sitagliptin

Intervention Type: DRUG

Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Interventions

SID1903 (FDC)

Single oral administration of SID1903 (FDC) after an overnight fast

Intervention Type: DRUG

Dapagliflozin and Sitagliptin

Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungbuk National University Hospital

Cheongju-si, , South Korea

Countries

South Korea

Other Identifiers

SID1903_001

Identifier Type: -

Identifier Source: org_study_id