A Pharmacokinetic Study of DW6012 (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 DW6012 and each component in healthy adult volunteers.

Official Title
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A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6012 and Loose-combination of Each Component in Healthy Adult Volunteers

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: DW6012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects aged up to 19 years 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 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 clinical laboratory tests, vital signs, physical examinations and 12-lead ECG 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, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history Subjects with genetic problems such as Lapp lactase deficiency (Lapp) or galactose intolerant galactose due to galactose intolerance Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries which may affect the absorption, distribution, metabolism and excretion of the IP 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 at the time of screening 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 ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months 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 eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling 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

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: DW6012 | Drug: DW6012<br>* Drug: DW6012 Single oral administration of DW6012 after an overnight fast Drug: Dapagliflozin and Sitagliptin Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast<br>* Other names: Dapagliflozin and Sitagliptin;|
| Experimental: Sequence B<br>Period 1: DW6012/ Period 2: Dapagliflozin and Sitagliptin | Drug: DW6012<br>* Drug: DW6012 Single oral administration of DW6012 after an overnight fast Drug: Dapagliflozin and Sitagliptin Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast<br>* Other names: Dapagliflozin and Sitagliptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t of Dapagliflozin and Sitagliptin |  | up to 48 hours | 
| Cmax of Dapagliflozin and Sitagliptin |  | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | up to 48 hours | 
| Tmax |  | up to 48 hours | 
| t1/2 |  | up to 48 hours | 
| CL/F |  | up to 48 hours | 
| Vd/F |  | up to 48 hours | 
| AUCextra |  | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, Sitagliptin, sitagliptin phosphate, Dapagliflozin propanediol