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Completed

NCT Number: NCT02176668

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

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

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei Medical Center Severance Hospital Clinical Trials Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
  • Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  • negative to Helicobacter pylori in 13C urea breath test
  • 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.
  • Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion criteria

  • 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.
  • 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.
  • Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
  • pregnant or lactating woman.
  • Other exclusions apply.

Treatment and study plan

YH4808 NF 100

Drug

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

YH4808 OF 200

Drug

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

YH4808 NF 200

Drug

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

YH4808 NF 400

Drug

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

Primary outcomes

  1. The Cmax of YH4808

    Time frame: Day 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

  2. The AUC0-24h of YH4808

    Time frame: Day 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

  3. The AUC0-24h of M3

    Time frame: Day 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

  4. The Cmax of M3

    Time frame: Day 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 outcomes

  1. the arithmetic mean of 24h intragastric pH monitoring

    Time frame: Day 1(Day7)~Day2(Day8)

  2. the median of 24h intragastric pH monitoring

    Time frame: Day 1(Day7)~Day2(Day8)

  3. The Duration of stomach maintained over pH4 or 5

    Time frame: Day 1(Day7)~Day2(Day8)

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2014
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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