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Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372850
Recruitment Status : Unknown
Verified January 2018 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: HIP1601 Drug: HGP1705 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : February 15, 2018
Estimated Primary Completion Date : June 15, 2018
Estimated Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence Group 1
Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)
Drug: HIP1601
Test Drug
Other Name: Esomeprazole (40 mg or 20 mg)

Drug: HGP1705
Reference Drug
Other Name: 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 Name: Esomeprazole (40 mg or 20 mg)

Drug: HGP1705
Reference Drug
Other Name: Nexium(esomeprazole 40 mg or 20 mg)




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. AUCinf 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

  2. Cmax 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

  3. Tmax 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

  4. Terminal Half-life 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

  5. CL/F 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

  6. Vd/F 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

  7. Ctrough [ Time Frame: 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 ]
    pharmacokinetic evaluation

  8. Ctrough,ss [ 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

  9. PTF [ 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

  10. RActrough [ 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

  11. After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours [ Time Frame: 1Day 24h pH monitoring ]
    pharmacodynamic evaluation

  12. After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours [ Time Frame: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring ]
    pharmacodynamic evaluation

  13. After the first administration and 7 days of repeated administration, The median pH measured for 24 hours [ Time Frame: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring ]
    pharmacodynamic evaluation

  14. After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours [ Time Frame: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h ]
    pharmacodynamic evaluation

  15. 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 [ Time Frame: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h ]
    pharmacodynamic evaluation

  16. After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours [ Time Frame: 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring ]
    pharmacodynamic evaluation


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372850


Contacts
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Contact: Sujin Kim, Pharm.D. +821065589053 sjk9053@hanmi.co.kr

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Contact: Injin Jang, M.D, Ph.D.         
Principal Investigator: In-Jin Jang, Ph.D         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03372850    
Other Study ID Numbers: HM-ESOM-101
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action