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

NCT07568652 | Completed Phase 1

• 1 other identifier: HL1113-102
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• Cmax

  48hr

Secondary Outcomes (1)

• AUC∞

  48hr

Study Arms (2)

Test group 1

EXPERIMENTAL

Drug: Test group 1

Test group 2

EXPERIMENTAL

Drug: Test group 2

Interventions

Test group 1 DRUG

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

Test group 1

Test group 2 DRUG

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

Test group 2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Central Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 6, 2026
• Study Start: October 16, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)