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

Aju Pharm

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: AJU-A51 Tab.; Drug: A51R1 Tab. and A51R2 Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04972539

20DM10202

Details and patient eligibility

About

To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults over the age of 19 years at the time of screening

2. 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

3. Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)

4. Individuals who agreed proper contraception during the study

5. 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

1. Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric

2. Individuals with an active chronic or acute disease within 1 month.

3. 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

4. Individuals with a severe allergies(except for allergic rhinitis or dermatitis)

5. 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.

6. 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

7. Individuals who cannot eat standard meal in institution

8. Women who are pregnant or may be pregnant

9. Individuals who were deemed to be inappropriate to participate in the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose

Treatment:

Drug: A51R1 Tab. and A51R2 Tab.

Drug: AJU-A51 Tab.

Sequence B

Experimental group

Description:

Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose

Treatment:

Drug: A51R1 Tab. and A51R2 Tab.

Drug: AJU-A51 Tab.