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Completed

NCT Number: NCT03558477

PK/PD Clinical Trial of YYD601 in Healthy Adult Male

A dose block-randomized, open-label, parallel clinical trial

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook national university hospital

Daegu, South Korea

About this study

This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult male above 19 years old when getting a screening test.
  • Subjects who have over 50kg weight, included in the IBW± 20% range. [IBW(kg)={height(cm)-100}x0.9
  • Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination.
  • Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated.
  • Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial.

Exclusion criteria

  • Subjects who are judged not suitable to participated in this trial.
  • Other specific exlusion criteria is identified in the protocol.

Treatment and study plan

YYD601 1

Drug

YYD601 1

YYD601 2

Drug

YYD601 2

YYD601 3

Drug

YYD601 3

Nexium

Drug

Nexium

Primary outcomes

  1. half-life

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)

  2. Tmax

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)

  3. Concentration

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Cmax(after singlidose), Cmax.ss(after repeated dose) Cmin.ss(after single dose),Cmin.ss(after single dose)

  4. AUC

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) AUClast(after singlidose), AUCt(after repeated dose) AUCinf(after single dose), AUCinf(after repeated dose)

Secondary outcomes

  1. Percent of pH>4 duration time

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    pH>4 duration time

  2. % change in serum gastrin level

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    serum gastrin level

Other outcomes

  1. Adverse event monitoring check up the adverse events

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    Adverse events

  2. Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature)

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    vital sign(blood-pressure, pulse rate, temparature)

  3. Adverse event monitoring check up the 12-lead EKG

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    12-lead EKG

  4. Adverse event monitoring check up the clinical laboratory test

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    clinical laboratory test

  5. Adverse event monitoring check up the physical

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    physical

  6. Adverse event monitoring check up the administraton about the combined drugs

    Time frame: Evaluate the before/after treatment period(5 days per phase)

    administraton about the combined drugs

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Dose Blocked-randomized, Open-label, Parallel Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 After Oral Administration in Healthy Adult Male Volunteers(Phase 1)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Jun 15, 2018

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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