CompletedNCT03882112Updated Sep 6, 2019

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

A Phase 1 interventional study of HIP1601 40mg in Heathy 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 2019-09-06.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: All

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 studied

Heathy Volunteer

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.

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).

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 24 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, orally
Also known as: HIP1601

What researchers measure

Primary outcomes

Cmax
Maximum observed concentration after dose
Time frame: Blood sampling during 24 hours after administration
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

Secondary outcomes

Tmax
Time of Cmax over the time span specified
Time frame: Blood sampling during 24 hours after administration
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
t1/2
Terminal half-life
Time frame: Blood sampling during 24 hours after administration
Clearance/F
Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf
Time frame: Blood sampling during 24 hours after administration
Vd/F
Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)
Time frame: Blood sampling during 24 hours after administration

Other outcomes

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
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
Median pH
Median intra-gastric pH for 24-hour interval after dose
Time frame: Blood sampling during 24 hours after administration
Integrated gastric acidity by time interval
Percent decrease from baseline in integrated gastric acidity after dose by time intervals
Time frame: Blood sampling during 24 hours after administration

Study locations

1 site

Seoul National University Biomedical Research Institute
Seoul, Korea, Republic of

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03882112
Lead sponsor: Hanmi Pharmaceutical Company Limited
Responsible party: Sponsor
First posted: Mar 20, 2019
Start date: Apr 17, 2019
Primary completion: Aug 28, 2019
Completion: Aug 28, 2019
Last update: Sep 6, 2019

Study contacts

Jang In-Jin, 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 Sep 2019. You cannot join it, but the record below documents what was studied.

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