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NCT07901088
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 19 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: AJU Pharm Co., Ltd.
Location: H+ Yangji Hospital Seoul Seoul
Summary
To evaluate the bioequivalence and safety of AJU-B718 and B718R in Healthy Adults.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 19 to less than 65 years at screening.
* Healthy adults without clinically significant congenital or chronic diseases.
* Considered eligible based on screening test results.
* BMI 18 to 30 kg/m², with body weight ≥50 kg for males and ≥45 kg for females.
* Provided written informed consent.
* Willing to comply with the specified contraception and reproductive restrictions.
Exclusion Criteria:
* Use of prohibited or potentially interfering medications within the specified period prior to the first administration.
* Excessive alcohol consumption within 1 month prior to the first administration.
* Participation in another clinical trial involving administration of an investigational product within 6 months prior to the first administration.
* Blood donation within the specified period prior to the first administration.
* History of gastrointestinal surgery that may affect drug absorption.
* Clinically significant bleeding disorders or other medical conditions that may affect study participation.
* History of clinically significant psychiatric disorders.
* Considered unsuitable for study participation by the Investigator or delegated physician.
* Pregnancy, suspected pregnancy, or breastfeeding in female participants.
Source: ClinicalTrials.gov (NCT07901088). StuddyBuddy aggregates publicly available trial information.