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CompletedNCT04204629Updated Nov 1, 2022

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

A Phase 1 interventional study of HIP1601 40mg in Healthy Volunteer, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Secondary objectives

  • To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male/Female healthy volunteers in the age between 19 and 50 years old.
  • Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
  • Helicobacter pylori (H. Pylori) negative.
  • After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  • Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion criteria

Exclusion Criteria:

  • Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
  • Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
  • Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
  • Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
  • Heavy smoker (>10 cigarettes/day).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Sequence 1

    Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601

    Drug: HIP1601 40mg

  • Experimental
    Sequence 2

    Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601

    Drug: HIP1601 40mg

Interventions

  • DrugHIP1601 40mg

    Single dosing of HIP1601 40mg, PO

    Also known as: HIP1601

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum observed concentration after dose

    Time frame: Blood sampling during 24 hours after administration

  2. Area Under the plasma concentration versus time Curve(AUC)last

    Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration

    Time frame: Blood sampling during 24 hours after administration

  3. Integrated gastric acidity for 24-hour

    Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose

    Time frame: Blood sampling during 24 hours after administration

Secondary outcomes

  1. Tmax

    Time of Cmax over the time span specified

    Time frame: Blood sampling during 24 hours after administration

  2. AUCinf

    Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely

    Time frame: Blood sampling during 24 hours after administration

  3. t1/2

    Terminal half-life

    Time frame: Blood sampling during 24 hours after administration

  4. Clearance/F

    Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf

    Time frame: Blood sampling during 24 hours after administration

  5. Vd/F

    Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)

    Time frame: Blood sampling during 24 hours after administration

  6. Duration of time intra-gastric pH 4.0 or higher

    Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose

    Time frame: Blood sampling during 24 hours after administration

  7. Median pH

    Median intra-gastric pH for 24-hour interval after dose

    Time frame: Blood sampling during 24 hours after administration

07

Study locations

1 site
  • Seoul National University Biomedical Research Institute
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04204629
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Dec 19, 2019
Start date
Jan 13, 2020
Primary completion
Feb 20, 2020
Completion
Feb 20, 2020
Last update
Nov 1, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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