Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03372850
• Other study ID #: HM-ESOM-101
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 8, 2017
• Last updated: January 14, 2018
• Start date: February 15, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: January 2018
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Sujin Kim, Pharm.D.
• Phone: +821065589053
• Email: sjk9053[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HIP1601
Test Drug
• HGP1705
Reference Drug

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours	pharmacodynamic evaluation	7Day 24h(Full time) pH monitoring
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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