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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: SID1903; Drug: SID1903-R1/SID1903-R2

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: SID1903-R1, SID1903-R2 / Period 2: SID1903	Drug: SID1903; Single oral administration of SID1903 after an overnight fast; Drug: SID1903-R1/SID1903-R2; Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast
Experimental: Sequence B; - Period 1: SID1903 / Period 2: SID1903-R1, SID1903-R2	Drug: SID1903; Single oral administration of SID1903 after an overnight fast; Drug: SID1903-R1/SID1903-R2; Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-t	up to 72hours
Cmax	up to 72hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax	up to 72hours
AUCinf	up to 72hours
t1/2	up to 72hours
CL/F	up to 72hours
Vd/F	up to 72hours
λz	up to 72hours
MRT	up to 72hours

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SID1903_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No