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The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176668
Enrollment
82
Registered
2014-06-27
Start date
2014-06-30
Completion date
2014-11-30
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Interventions

DRUGYH4808 NF 100

The number of times : multiple-dose Rout : oral administration

DRUGYH4808 OF 200

The number of times : multiple-dose Rout : oral administration

DRUGYH4808 NF 200

The number of times : multiple-dose Rout : oral administration

DRUGYH4808 NF 400

The number of times : multiple-dose Rout : oral administration

Sponsors

Yuhan Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 \ 25 2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result 3. negative to Helicobacter pylori in 13C urea breath test 4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration. 5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion criteria

1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement. 2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP. 3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.) 4. pregnant or lactating woman. 5. Other exclusions apply.

Design outcomes

Primary

MeasureTime frameDescription
The Cmax of YH4808Day 1(Day 35), Day 7(Day 41)Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The AUC0-24h of YH4808Day 1(Day 35), Day 7(Day 41)Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The AUC0-24h of M3Day 1(Day 35), Day 7(Day 41)Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The Cmax of M3Day 1(Day 35), Day 7(Day 41)Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing

Secondary

MeasureTime frame
the median of 24h intragastric pH monitoringDay 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5Day 1(Day7)~Day2(Day8)
the arithmetic mean of 24h intragastric pH monitoringDay 1(Day7)~Day2(Day8)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026