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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: SID1903 (FDC)
* Drug: Dapagliflozin and Sitagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC) | Drug: SID1903 (FDC)<br>* Single oral administration of SID1903 (FDC) after an overnight fast<br>Drug: Dapagliflozin and Sitagliptin<br>* Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast<br>|
| Experimental: Sequence B<br>Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin | Drug: SID1903 (FDC)<br>* Single oral administration of SID1903 (FDC) after an overnight fast<br>Drug: Dapagliflozin and Sitagliptin<br>* Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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