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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AJU-A51 Tab.

A51R1 Tab. and A51R2 Tab.

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults over the age of 19 years at the time of screening
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
Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
Individuals who agreed proper contraception during the study
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:

Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
Individuals with an active chronic or acute disease within 1 month.
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
Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
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.
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
Individuals who cannot eat standard meal in institution
Women who are pregnant or may be pregnant
Individuals who were deemed to be inappropriate to participate in the study by the investigator

Sites / Locations

Jang Hee Hong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence A

Sequence B

Arm Description

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

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

Outcomes

Primary Outcome Measures

AUCt(Area Under Curve last) of AJU-A51

Area under the plasma concentration time curve of AJU-A51

Cmax

The maximum concentration observed of AJU-A51 over blood sampling time.

Secondary Outcome Measures

Full Information

NCT ID

NCT04972539

First Posted

July 12, 2021

Last Updated

July 20, 2021

Sponsor

AJU Pharm Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04972539

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AJU Pharm Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence A

Arm Type

Experimental

Arm Description

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

Arm Title

Sequence B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AJU-A51 Tab.

Other Intervention Name(s)

Test drug

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

A51R1 Tab. and A51R2 Tab.

Other Intervention Name(s)

Reference drug

Intervention Description

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

Primary Outcome Measure Information:

Title

AUCt(Area Under Curve last) of AJU-A51

Description

Area under the plasma concentration time curve of AJU-A51

Time Frame

predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose

Title

Cmax

Description

The maximum concentration observed of AJU-A51 over blood sampling time.

Time Frame

predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults over the age of 19 years at the time of screening 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 Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.) Individuals who agreed proper contraception during the study 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: Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric Individuals with an active chronic or acute disease within 1 month. 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 Individuals with a severe allergies(except for allergic rhinitis or dermatitis) 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. 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 Individuals who cannot eat standard meal in institution Women who are pregnant or may be pregnant Individuals who were deemed to be inappropriate to participate in the study by the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jang Hee Hong

Organizational Affiliation

Chungnam National University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jang Hee Hong

City

Daejeon

State/Province

Korea

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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