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Clinical Trials/NCT07598968
NCT07598968CompletedPhase 1

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

Hanlim Pharm. Co., Ltd.1 site in 1 country35 target enrollmentStarted: June 18, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
35
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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