Clinical trial NCT04972539: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUCt(Area Under Curve last) of AJU-A51
timeFrame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
measure: Cmax
timeFrame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Jang Hee Hong
state: Korea
Study officials:
affiliation: Chungnam National University
name: Jang Hee Hong
role: PRINCIPAL_INVESTIGATOR
References: