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

NCT04970940 | Completed Phase 1

• 1 other identifier: 20DM10201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

• AUCτ of AJU-A51R1 and AJU-A51R2

  Area Under Curve tau

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose

• Css,max of AJU-A51R1 and AJU-A51R2

  Cmax, steady state

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose

Study Arms (1)

Sequence 1

EXPERIMENTAL

* 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)

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Interventions

Treatment A DRUG

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

Also known as: Period 1

Sequence 1

Treatment B DRUG

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

Also known as: Period 2

Sequence 1

Treatment C DRUG

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

Also known as: Period 3

Sequence 1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals whose age is over 19 and under 65 years old when visiting for initial screening test.
• 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) .
• Individuals with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area.
• 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.
• 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.
• Individuals who agreed proper contraception during the study
• The participants must have an ability and willingness to participate throughout the entire trials.

You may not qualify if:

• 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.
• 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).
• Individual who had following results after examination(a. ALT or AST \> twice higher than Upper limit of normal value).
• 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).
• Individual whose blood pressure \< 90 or ≥160(systolic blood pressure) or \< 50 or ≥ 100(diastolic blood pressure).
• 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)).
• Individual who had a medical history of alcohol and drug abuses.
• 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.
• Individual who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
• A person who is not determined unsuitable to participate in this test by the researchers.

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Min-gul Kim

Jeonju, Korea, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Min-gul Kim

  Jeonbuk University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: July 2, 2020
• Primary Completion: October 7, 2020
• Study Completion: December 31, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

KR (1)