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

NCT05453786 | Completed Phase 1

• 1 other identifier: SID1903_002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC0-t

  up to 72hours

• Cmax

  up to 72hours

Secondary Outcomes (7)

• Tmax

  up to 72hours

• AUCinf

  up to 72hours

• t1/2

  up to 72hours

• CL/F

  up to 72hours

• Vd/F

  up to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: SID1903-R1, SID1903-R2 / Period 2: SID1903

Drug: SID1903; Drug: SID1903-R1/SID1903-R2

Sequence B

EXPERIMENTAL

\- Period 1: SID1903 / Period 2: SID1903-R1, SID1903-R2

Drug: SID1903; Drug: SID1903-R1/SID1903-R2

Interventions

SID1903 DRUG

Single oral administration of SID1903 after an overnight fast

Sequence A; Sequence B

SID1903-R1/SID1903-R2 DRUG

Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Related Publications (1)

• Lukka PB, Tang W, Hammarstedt A, Conrad T, Heijer M, Karlsson C, Boulton DW. Racial Comparison of the Pharmacokinetics and Safety of Fixed-dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. Clin Ther. 2024 Sep;46(9):717-725. doi: 10.1016/j.clinthera.2024.07.007. Epub 2024 Aug 23.

  PMID: 39179458 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 12, 2022
• Study Start: June 23, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 11, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)