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CompletedNCT07581028Updated Sep 9, 2026

Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers

A Phase 1 interventional study of Test Drug and Reference Drug in Hypercholerolemia and Dyslipidemia, sponsored by AJU Pharm Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by AJU Pharm Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
19 Years to 59 Years
Sex
All
01

Study summary

To Evaluate the Safety and Pharmacokinetics of "AJU-C715" and "C715R" in Healthy Adults.

02

Conditions studied

  • Hypercholerolemia
  • Dyslipidemia

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 61 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

AJU Pharm Co., Ltd. is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adults aged 19 to less than 60 years at the time of screening
  2. 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.
  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 the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
  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 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.

Exclusion criteria

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 taking cyclosporin
  • Those with Myopathy
  • Those with severe Renal Impairment due to Renal Failure
  • 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Sequence A

    Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose

    Drug: Test Drug · Drug: Reference Drug

  • Experimental
    Sequence B

    Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose

    Drug: Test Drug · Drug: Reference Drug

Interventions

  • DrugTest Drug

    AJU-C715

  • DrugReference Drug

    C715R

06

What researchers measure

Primary outcomes

  1. AUCt of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

  2. Cmax of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

Secondary outcomes

  1. AUC∞ of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

  2. AUCt/AUC∞ of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

  3. Tmax of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

  4. t1/2 of AJU-C715

    Time frame: Pre-dose(0 hours) ~ 72 hours

07

Study locations

1 site
  • H+ Yangji Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07581028
Lead sponsor
AJU Pharm Co., Ltd.
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Aug 6, 2026
Primary completion
Aug 24, 2026
Completion
Aug 28, 2026
Last update
Sep 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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