To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults

NCT06933459 | Active Not Recruiting Phase 1

• 1 other identifier: 24PHL10102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• AUCt of AJU-C714

  Pre-dose(0 hours), 3, 5, 10, 15, 20, 30, 40, 50 minutes, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours

• Cmax of AJU-C714

  Pre-dose(0 hours), 3, 5, 10, 15, 20, 30, 40, 50 minutes, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Reference Drug, single dose Period 2: Test Drug, single dose

Drug: Test Drug; Drug: Reference Drug

Sequence B

EXPERIMENTAL

Period 1: Test Drug, single dose Period 2: Reference Drug, single dose

Drug: Test Drug; Drug: Reference Drug

Interventions

Test Drug DRUG

AJU-C714

Sequence A; Sequence B

Reference Drug DRUG

C714R

Sequence A; Sequence B

Eligibility Criteria

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

You may qualify if:

• Healthy adult over 19 years of age and under 65 years of age.
• Weight ≥ 50 kg (man) or 45 kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2.
• Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests.
• Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial.
• Those who agree to contraception during the participation of clinical trial.

You may not qualify if:

• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
• Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
• Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
• Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
• Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
• Those who has under
• Those who are hypersensitive to component of the Investigational product and have the medical history
• Those with active liver disease or persistent elevation of aminotransferase levels of unknown
• Those with myopathy
• Those taking cyclosporin
• Those with renal impairment with severe renal failure
• Those with Hypothyroidism
• Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
• Those who has a history of mental illness.
• Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

H+ Yangji Hospital, Seoul, Republic of South Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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: April 11, 2025
• First Posted: April 18, 2025
• Study Start: May 24, 2025
• Primary Completion: June 11, 2025
• Study Completion: June 24, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

KR (1)