Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults

Study Overview
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Brief Summary
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To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

Detailed Description
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This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.

Official Title
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A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: AJU-A51 Tab.
* Drug: A51R1 Tab. and A51R2 Tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults over the age of 19 years at the time of screening Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg * BMI = Weight(kg)/ Height(m)2 Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.) Individuals who agreed proper contraception during the study Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation Exclusion Criteria: Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric Individuals with an active chronic or acute disease within 1 month. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption Individuals with a severe allergies(except for allergic rhinitis or dermatitis) Individuals with the following medical histories at screening test: T1DM or diabetic ketoacidosis Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc. Renal disorder or pancreatitis etc. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first Individuals who cannot eat standard meal in institution Women who are pregnant or may be pregnant Individuals who were deemed to be inappropriate to participate in the study by the investigator

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: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose | Drug: AJU-A51 Tab.<br>* Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet<br>* Other names: Test drug;Drug: A51R1 Tab. and A51R2 Tab.<br>* Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together<br>* Other names: Reference drug;|
| Experimental: Sequence B<br>Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose | Drug: AJU-A51 Tab.<br>* Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet<br>* Other names: Test drug;Drug: A51R1 Tab. and A51R2 Tab.<br>* Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together<br>* Other names: Reference drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt(Area Under Curve last) of AJU-A51 | Area under the plasma concentration time curve of AJU-A51 | predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose | 
| Cmax | The maximum concentration observed of AJU-A51 over blood sampling time. | predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose |