NCT07598968

CompletedPhase 1

Clinical Trial to Evaluate the Safety and Pharmacokinetic Ch...

Hanlim Pharm. Co., Ltd.Source

Hanlim Pharm. Co., Ltd.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

HL1113-101

Study Type

interventional

Actual enrollment (reported)

35

Locations

1 country

Sites

1

Timeline

Study Start

June 18, 2023

Actual (reported)

Primary Completion

July 12, 2023

Actual (reported)

Study Completion

July 12, 2023

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 35 participants
Study completion date: July 12, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 18, 2023
Actual (reported)
Primary Completion
July 12, 2023
Actual (reported)
Study Completion
July 12, 2023
Actual (reported)
First Submitted
April 13, 2026
Actual (reported)
First Posted
May 20, 2026
Actual (reported)

Last Updated: May 20, 2026
Status Verified: May 2026
Last Update Submitted: May 14, 2026

Conditions

Diabete Type 2 Hypertension

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 1Drug

* 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 2Drug

* 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

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

Hanlim Pharm. Co., Ltd.
Industrylead

Study Sites (1)

Central Hospital

Seoul, South Korea

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Enrollment

35 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

Phase 1Completed

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

July 12, 2023

Actual (reported)

Study Completion

July 12, 2023

Actual (reported)

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07598968
Data provider: ClinicalTrials.gov
Source updated: 2026-05-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:14 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Test group 1

Test group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations