NCT03372850

Brief Summary

This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

December 8, 2017

Last Update Submit

January 14, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUClast of esomeprazole

    pharmacokinetic evaluation

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours

    pharmacodynamic evaluation

    7Day 24h(Full time) pH monitoring

Secondary Outcomes (16)

  • AUCinf of esomeprazole

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • Cmax of esomeprazole

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • Tmax of esomeprazole

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • Terminal Half-life of esomeprazole

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • CL/F of esomeprazole

    1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour

  • +11 more secondary outcomes

Other Outcomes (1)

  • After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time

    1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring

Study Arms (2)

Sequence Group 1

EXPERIMENTAL

Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)

Drug: HIP1601Drug: HGP1705

Sequence Group 2

EXPERIMENTAL

Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)

Drug: HIP1601Drug: HGP1705

Interventions

HIP1601DRUG

Test Drug

Also known as: Esomeprazole (40 mg or 20 mg)
Sequence Group 1Sequence Group 2
HGP1705DRUG

Reference Drug

Also known as: Nexium(esomeprazole 40 mg or 20 mg)
Sequence Group 1Sequence Group 2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19\~50 years in healthy male volunteers
  • BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Sujin Kim, Pharm.D.

CONTACT

+821065589053sjk9053@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 14, 2017

Study Start

February 15, 2018

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)