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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972539
• Other study ID #: 20DM10202
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2020
• Est. completion date: March 9, 2021

Study information

• Verified date: July 2021
• Source: AJU Pharm Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 9, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• AJU-A51 Tab.
Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
• A51R1 Tab. and A51R2 Tab.
Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Locations

Country	Name	City	State
Korea, Republic of	Jang Hee Hong	Daejeon	Korea

Sponsors (1)

Lead Sponsor	Collaborator
AJU Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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