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OpenTrials
Completed

NCT Number: NCT07655960

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

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

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H+ Yangji Hospital, Seoul, Republic of South Korea

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Women who are pregnant or who may be pregnant and breastfeed.

Treatment and study plan

Test Drug

Drug

AJU-C716

Reference Drug

Drug

C716R

Primary outcomes

  1. AUCt of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

  2. Cmax of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

Secondary outcomes

  1. Ka of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

  2. Percentage of concentration relative to Cmax of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

  3. AUCinf of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

  4. AUCt/AUCinf of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

  5. t1/2 of AJU-C716

    Time frame: Pre-dose(0 hours) ~ 36 hours

Sponsors and collaborators

Lead sponsor

AJU Pharm Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over to Evaluate the Safety and Pharmacokinetics of AJU-C716 Compared to C716R in Healthy Adult Volunteers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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