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Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects

NCT03882112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-09-06

No results posted yet for this study

Summary

Primary objective

\- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Secondary objectives

* To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
* To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Conditions

  • Heathy Volunteer

Interventions

DRUG

HIP1601 40mg

Single dosing of HIP1601 40mg, orally

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Jang In-Jin, MD · Seoul National University Hospital, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2019-08-28
Completion
2019-08-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882112 on ClinicalTrials.gov