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

An Open-label, Multiple Dose, Crossover Study to Evaluate the Drug-drug Interaction Between AJU-A51R1 and AJU-A51R2 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Jeonju, Korea, Korea, Republic of
      • Min-gul Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Treatment A; AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days; Other Names: Period 1; Drug: Treatment B; AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days; Other Names: Period 2; Drug: Treatment C; AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days; Other Names: Period 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.
• Investigators: Principal Investigator: Min-gul Kim, Jeonbuk University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): October 7, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20DM10201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No