Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers

NCT07598968 | Completed Phase 1 DMC

• 1 other identifier: HL1113-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers

Conditions

Hypertension; Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• AUCτ,ss

  a steady state after 5~7 days of repeated administration

Secondary Outcomes (1)

• Tmax,ss

  a steady state after 5~7 days of repeated administration

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: HL1113-R1, once daily, administered for 7 days * Period 2: HL1113-R1 + HL1113-R2 once daily, administered for 7 days

Test group 1

Test group 2 DRUG

* Period 1: HL1113-R2, once daily, administered for 5 days * Period 2: HL1113-R2 + HL1113-R1 once daily, administered for 7 days

Test group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult subjects aged ≥19 years at the time of screening
• Subjects with no clinically significant congenital or chronic diseases based on screening, and no clinically significant findings on internal medicine examination (including, if necessary, electroencephalogram \[EEG\], electrocardiogram \[ECG\], chest examination, upper gastrointestinal endoscopy, or gastrointestinal radiography)
• etc.

You may not qualify if:

• Subjects who have received medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to the screening visit
• Subjects who have received any medications that may affect the outcome of the study within 10 days prior to the screening visit
• 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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 20, 2026
• Study Start: June 18, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)