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

A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: AJU-A51 Tab.; Drug: A51R1 Tab. and A51R2 Tab.

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Daejeon, Korea, Korea, Republic of
      • Jang Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: AJU-A51 Tab.; Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet; Other Names: Test drug; Drug: A51R1 Tab. and A51R2 Tab.; Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together; Other Names: Reference drug
Experimental: 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	Drug: AJU-A51 Tab.; Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet; Other Names: Test drug; Drug: A51R1 Tab. and A51R2 Tab.; Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together; Other Names: Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt(Area Under Curve last) of AJU-A51	Area under the plasma concentration time curve of AJU-A51	predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Cmax	The maximum concentration observed of AJU-A51 over blood sampling time.	predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.
• Investigators: Principal Investigator: Jang Hee Hong, Chungnam National University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 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: 20DM10202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No