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YH4808 Postprandial PK/PD Study in Healthy Subjects

NCT ID: NCT01761513

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-02-28

Brief Summary

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A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

YH4808

Intervention Type DRUG

Group1

1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks

YH4808

Intervention Type DRUG

Group2

1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks

YH4808

Intervention Type DRUG

Group3

1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks

YH4808

Intervention Type DRUG

Group 4

1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Sequence 2

Group Type EXPERIMENTAL

YH4808

Intervention Type DRUG

Group1

1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks

YH4808

Intervention Type DRUG

Group2

1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks

YH4808

Intervention Type DRUG

Group3

1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks

YH4808

Intervention Type DRUG

Group 4

1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Sequence 3

Group Type ACTIVE_COMPARATOR

YH4808

Intervention Type DRUG

Group1

1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks

YH4808

Intervention Type DRUG

Group2

1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks

YH4808

Intervention Type DRUG

Group3

1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks

YH4808

Intervention Type DRUG

Group 4

1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Sequence 4

Group Type ACTIVE_COMPARATOR

YH4808

Intervention Type DRUG

Group1

1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks

YH4808

Intervention Type DRUG

Group2

1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks

YH4808

Intervention Type DRUG

Group3

1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks

YH4808

Intervention Type DRUG

Group 4

1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Interventions

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YH4808

Group1

1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks

Intervention Type DRUG

YH4808

Group2

1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks

Intervention Type DRUG

YH4808

Group3

1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks

Intervention Type DRUG

YH4808

Group 4

1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Intervention Type DRUG

Other Intervention Names

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YH4808, Nexium Nexium

Eligibility Criteria

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Inclusion Criteria

1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
3. Subject who shows negative reaction of UBT(Urea Breath Test)
4. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
6. Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
3. Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
4. Other exclusions apply
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minsoo Park, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System(Severance Hospital)

Locations

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Yonsei University Health System(Severance Hospital)

Seoul, Seodaemun-gu,Sinchon-dong, South Korea

Site Status

Countries

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South Korea

References

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Yoon S, Oh E, Park MS, Jang SB, Byun HM, Park H, Kim H, Kim CO. Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen. Transl Clin Pharmacol. 2021 Sep;29(3):150-159. doi: 10.12793/tcp.2021.29.e15. Epub 2021 Sep 17.

Reference Type DERIVED
PMID: 34621707 (View on PubMed)

Other Identifiers

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YH4808-107

Identifier Type: -

Identifier Source: org_study_id

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