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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07568652

Enrollment

Registered

2026-05-06

Start date

2024-10-16

Completion date

2024-11-15

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2, Hypertension

Brief 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

Interventions

DRUGTest group 1

* Period 1 : HL1113R1 + HL1113R2, once daily * Period 2 : HL1113, once daily

DRUGTest group 2

* Period 1 : HL1113, once daily * Period 2 : HL1113R1 + HL1113R2, once daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cmax	48 hours after administration

Secondary

Measure	Time frame
AUC∞	48 hours after administration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026