Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: HIP1601; Drug: HGP1705

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sujin Kim, Pharm.D.; Phone Number: +821065589053; Email: sjk9053@hanmi.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
    • Contact: Injin Jang, M.D, Ph.D.
    • Principal Investigator: In-Jin Jang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age 19~50 years in healthy male volunteers
2. BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2
3. 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:

1. 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
2. Subjects who judged ineligible by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group 1; Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)	Drug: HIP1601; Test Drug; Other Names: Esomeprazole (40 mg or 20 mg); Drug: HGP1705; Reference Drug; Other Names: Nexium(esomeprazole 40 mg or 20 mg)
Experimental: Sequence Group 2; Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)	Drug: HIP1601; Test Drug; Other Names: Esomeprazole (40 mg or 20 mg); Drug: HGP1705; Reference Drug; Other Names: Nexium(esomeprazole 40 mg or 20 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf 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
Cmax 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
Tmax 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
Terminal Half-life 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
CL/F 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
Vd/F 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
Ctrough	pharmacokinetic evaluation	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
Ctrough,ss	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
PTF	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
RActrough	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 the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours	pharmacodynamic evaluation	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 for 24 hours	pharmacodynamic evaluation	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	pharmacodynamic evaluation	1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours	pharmacodynamic evaluation	1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
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	pharmacodynamic evaluation	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	pharmacodynamic evaluation	1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time	exploratory endpoint	1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2018
• Primary Completion (Anticipated): June 15, 2018
• Study Completion (Anticipated): June 15, 2018

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 14, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: HM-ESOM-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No