The Drug-drug Interaction Study of AJU-A51R1 and AJU-A51R2

NCT ID: NCT04970940

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2020-12-31

Brief Summary

To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers.

Detailed Description

This study is to investigate drug-drug interaction between AJU-A51R1 and AJU-A51R2.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

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

Study Groups

Sequence 1

• Period 1: Treatment A(AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days)
• Wash-out for 7 days
• Period 2: Treatment B(AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days)
• Period 3: Treatment C(AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days)

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days

Treatment B

Intervention Type: DRUG

AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days

Treatment C

Intervention Type: DRUG

AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days

Interventions

Treatment A

AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days

Intervention Type: DRUG

Treatment B

AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days

Intervention Type: DRUG

Treatment C

AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days

Intervention Type: DRUG

Other Intervention Names

Period 1; Period 2; Period 3

Eligibility Criteria

Inclusion Criteria

1. Individuals whose age is over 19 and under 65 years old when visiting for initial screening test.

2. Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55 kg(men) or 45 kg(women) (Body mass index (BMI) = weight (kg) / height (m)^2) .

3. Individuals with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area.

4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.

5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.

6. Individuals who agreed proper contraception during the study

7. The participants must have an ability and willingness to participate throughout the entire trials.

Exclusion Criteria

1. Individuals with a medical evidence or a history (excluding dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease.

2. Individual who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy).

3. Individual who had following results after examination(a. ALT or AST > twice higher than Upper limit of normal value).

4. Individual Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12g).

5. Individual whose blood pressure < 90 or ≥160(systolic blood pressure) or < 50 or ≥ 100(diastolic blood pressure).

6. Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within 180 days prior to the first dose of this study(except when subject have not taken investigational product(s)).

7. Individual who had a medical history of alcohol and drug abuses.

8. Individual who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug.

9. Individual who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.

10. A person who is not determined unsuitable to participate in this test by the researchers.

• 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

Min-gul Kim

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk University Hospital

Locations

Min-gul Kim

Jeonju, Korea, South Korea

Countries

South Korea

Other Identifiers

20DM10201

Identifier Type: -

Identifier Source: org_study_id