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NCT07568652CompletedPhase 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

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

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
37 (actual)
First submitted
13 Apr 2026
Start date
16 Oct 2024
Primary completion date
15 Nov 2024
Lead sponsor
Hanlim Pharm. Co., Ltd.
NCT number
NCT07568652

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 37
  • From 16 Oct 2024 to the primary completion date, 15 Nov 2024
  • 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

  • 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)

Other

  • etc.

Who the study is looking for

  • 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.

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
Central Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

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