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

NCT ID: NCT04972539

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-03-09

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A

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

Group Type: EXPERIMENTAL

AJU-A51 Tab.

Intervention Type: DRUG

Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet

A51R1 Tab. and A51R2 Tab.

Intervention Type: DRUG

Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Sequence B

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

Group Type: EXPERIMENTAL

AJU-A51 Tab.

Intervention Type: DRUG

Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet

A51R1 Tab. and A51R2 Tab.

Intervention Type: DRUG

Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Interventions

AJU-A51 Tab.

Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet

Intervention Type: DRUG

A51R1 Tab. and A51R2 Tab.

Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Intervention Type: DRUG

Other Intervention Names

Test drug; Reference drug

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AJU Pharm Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jang Hee Hong

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University

Locations

Jang Hee Hong

Daejeon, Korea, South Korea

Countries

South Korea

Other Identifiers

20DM10202

Identifier Type: -

Identifier Source: org_study_id