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To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose |
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| Sequence B | Experimental | Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AJU-A51 Tab. | Drug | Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet |
|
| 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 |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hee Hong | Chungnam National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jang Hee Hong | Daejeon | Korea | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| A51R1 Tab. and A51R2 Tab. | Drug | Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together |
|
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| D004700 | Endocrine System Diseases |