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

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C714 Compared to C714R in Healthy Adult Volunteers

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Test Drug; Drug: Reference Drug

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • H+ Yangji Hospital, Seoul, Republic of South Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult over 19 years of age and under 65 years of age.
2. Weight ≥ 50 kg (man) or 45 kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2.
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests.
5. 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.
6. Those who agree to contraception during the participation of clinical trial.

Exclusion Criteria:

1. 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.
2. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
3. 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.
4. Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
5. 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.

6. 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
7. Those who has a history of mental illness.
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
9. Women who are pregnant or who may be pregnant and breastfeed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: Reference Drug, single dose Period 2: Test Drug, single dose	Drug: Test Drug; AJU-C714; Drug: Reference Drug; C714R
Experimental: Sequence B; Period 1: Test Drug, single dose Period 2: Reference Drug, single dose	Drug: Test Drug; AJU-C714; Drug: Reference Drug; C714R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2025
• Primary Completion (Estimated): June 11, 2025
• Study Completion (Estimated): June 24, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 24PHL10102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No