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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07901088). StuddyBuddy aggregates publicly available trial information.