Clinical Trial to Evaluate the Pharmacokinetics and Safety Between the Single Administration of H… (NCT07568652) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial to Evaluate the Pharmacokinetics and Safety Between the Single Administration of HL1113 and the Concomitant Administration of HL1113R1 and HL1113R2 for Healthy Subjects in Fasting State
South Korea37 participantsStarted 2024-10-16
Plain-language summary
This clinical trial is a randomized, open-label, single oral dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the single administration of HL1113 and the concomitant administration of HL1113R1 and HL1113R2 for healthy subjects in fasting state
Who can participate
Age range19 Years – 65 Years
SexALL
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Inclusion Criteria:
* Subjects aged ≥19 years and \<65 years at the time of screening
* Subjects with a body mass index (BMI) of 18.0 to 30.0 kg/m² at screening(BMI calculated as: weight \[kg\] / height \[m\]²)
* etc.
Exclusion Criteria:
* Subjects who have taken medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to study initiation (first dose), or who have taken medications that may affect the outcome of the study within 10 days prior to study initiation (first dose). However, participation may be allowed if, based on pharmacokinetic/pharmacodynamic characteristics (e.g., drug interactions, half-life of concomitant medications), the investigator determines that such medications will not affect the study
* Subjects who have participated in a bioequivalence study or any other clinical trial and received an investigational product within 6 months prior to study initiation (first dose)
* etc.