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NCT07901114Not yet recruitingPhase 1

A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers

A Randomized, Open-Label, Fasting, 2-Period, 2-Sequence Crossover Study to Evaluate the Bioequivalence and Safety of AJU-C719 and C719R in Healthy Adult Volunteers

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

To evaluate the bioequivalence and safety of "AJU-C719" and "C719R" in healthy adult subjects.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Oct 2026
Start date
Nov 2026
Primary completion date
Dec 2026
Lead sponsor
AJU Pharm Co., Ltd.
NCT number
NCT07901114

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 60
  • From Nov 2026 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of prohibited medications or medications that may affect the study within the specified period before the first dose
  • Participation in another clinical trial within the previous 6 months

Other illness

  • History of gastrointestinal surgery that may affect drug absorption
  • Clinically significant medical conditions or contraindications to the study drugs
  • Clinically significant psychiatric disorders
  • Any other condition considered inappropriate for study participation by the Investigator

Other

  • Excessive alcohol consumption
  • Blood donation within the specified period before the first dose
  • Pregnancy or breastfeeding

Who the study is looking for

  • Adults aged 19 to less than 65 years at screening.
  • Healthy adults without clinically significant medical conditions
  • BMI 18-30 kg/m² (men ≥50 kg; women ≥45 kg)
  • Considered eligible based on screening examinations and laboratory tests
  • Willing to provide written informed consent
  • Willing to comply with the contraception and reproductive restrictions during the specified study period

Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bumin Hospital (Seoul)
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.