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

NCT04972539 | Completed Phase 1

• 1 other identifier: 20DM10202
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence A

EXPERIMENTAL

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.; Drug: A51R1 Tab. and A51R2 Tab.

Sequence B

EXPERIMENTAL

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.; Drug: A51R1 Tab. and A51R2 Tab.

Interventions

AJU-A51 Tab. DRUG

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

Also known as: Test drug

Sequence A; Sequence B

A51R1 Tab. and A51R2 Tab. DRUG

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

Also known as: Reference drug

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Jang Hee Hong

Daejeon, Korea, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Jang Hee Hong

  Chungnam National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: August 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: March 9, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

KR (1)