PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Eligibility criteria

Qualifiers

Male or female participants aged ≥19 years and <65 years at the time of screening

Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)

Disqualifiers

Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.

Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.

Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).

Trial design

Treatments tested in this trial

  • DWJ1511
  • DWC202501

Treatment groups

60 Participants
are divided into 2 treatment groups