Clinical Trials/NCT03372850

NCT03372850

Unknown

Phase 1

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

Hanmi Pharmaceutical Company Limited1 site in 1 country96 target enrollmentFebruary 15, 2018

ConditionsHealthy

InterventionsHIP1601 HGP1705

DrugsHIP1601 HGP1705

Overview

Phase: Phase 1
Intervention: HIP1601
Conditions: Healthy
Sponsor: Hanmi Pharmaceutical Company Limited
Enrollment: 96
Locations: 1
Primary Endpoint: AUClast of esomeprazole
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Detailed Description

This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Registry

clinicaltrials.gov

Start Date

February 15, 2018

End Date

June 15, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Hanmi Pharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Sequence Group 2

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

Intervention: HIP1601

Sequence Group 1

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

Intervention: HGP1705

Sequence Group 1

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

Intervention: HIP1601

Sequence Group 2

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

Intervention: HGP1705

Outcomes

Primary Outcomes

AUClast of esomeprazole

Time Frame: 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

pharmacokinetic evaluation

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

Time Frame: 7Day 24h(Full time) pH monitoring

pharmacodynamic evaluation

Secondary Outcomes

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)
Ctrough(1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 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, 2 Day 0 hour)
PTF(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 first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours(1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h)
After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours(1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring)
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)
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)
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)
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)
Vd/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)
RActrough(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)
Ctrough,ss(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 the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours(1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring)
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours(1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring)
After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours(1Day 24h pH monitoring)
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours(1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h)