Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: AJU-A51 Tab.Drug: A51R1 Tab. and A51R2 Tab.
- Registration Number
- NCT04972539
- Lead Sponsor
- AJU Pharm Co., Ltd.
- Brief Summary
To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
-
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
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Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
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Individuals who agreed proper contraception during the study
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Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
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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.
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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
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Individuals who were deemed to be inappropriate to participate in the study by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A AJU-A51 Tab. Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Sequence A A51R1 Tab. and A51R2 Tab. Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Sequence B AJU-A51 Tab. Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Sequence B A51R1 Tab. and A51R2 Tab. Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose
- Primary Outcome Measures
Name Time Method AUCt(Area Under Curve last) 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 Area under the plasma concentration time curve of AJU-A51
Cmax predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose The maximum concentration observed of AJU-A51 over blood sampling time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jang Hee Hong
🇰🇷Daejeon, Korea, Korea, Republic of