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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04972539

Enrollment

Registered

2021-07-22

Start date

2020-08-01

Completion date

2021-03-09

Last updated

2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGAJU-A51 Tab.

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

DRUGA51R1 Tab. and A51R2 Tab.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026