To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

NCT07655960 | Completed Phase 1

• 1 other identifier: 26PHL12001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

Conditions

Dyslipidemia; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• AUCt of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

• Cmax of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

Secondary Outcomes (5)

• Ka of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

• Percentage of concentration relative to Cmax of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

• AUCinf of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

• AUCt/AUCinf of AJU-C716

  Pre-dose(0 hours) ~ 36 hours

• t1/2 of AJU-C716

  Pre-dose(0 hours) ~ 36 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-C716

Sequence A; Sequence B

Reference Drug DRUG

C716R

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between 19 and 55 years of age at the time of screening.
• Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.
• 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 the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
• 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 use highly effective methods of contraception(excluding hormonal methods) to prevent pregnancy, either for themselves or their spouse/partner, from the first administration of the investigational medicinal product until one week after the last administration, and who agree not to donate sperm or eggs during this period.

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
• Individuals with severe hepatic impairment, biliary obstruction, or cholestasis
• Those taking cyclosporin
• Those with myopathy
• Those with a history of hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5, Sunset Yellow FCF).
• 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

Hypercholesterolemia; Dyslipidemias

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Hyperlipidemias; 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 9, 2026
• First Posted: June 18, 2026
• Study Start: June 11, 2026
• Primary Completion: June 19, 2026
• Study Completion: July 3, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

KR (1)