PK/PD Clinical Trial of YYD601 in Healthy Adult Male

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2018-02-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each arm is assignted 10 persons\[the percent of each arm is (treatmnet: comparator=4:1)\]

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Set 1(YYD601 1 & Nexium)

Set 1: YYD601 1 \& Nexium

Group Type EXPERIMENTAL

YYD601 1

Intervention Type DRUG

YYD601 1

Nexium

Intervention Type DRUG

Nexium

Set 2(YYD601 2 & Nexium)

Set 2: YYD601 2 \& Nexium

Group Type EXPERIMENTAL

YYD601 2

Intervention Type DRUG

YYD601 2

Nexium

Intervention Type DRUG

Nexium

Set 3(YYD601 3 & Nexium)

Set 3:YYD601 3 \& Nexium

Group Type EXPERIMENTAL

YYD601 3

Intervention Type DRUG

YYD601 3

Nexium

Intervention Type DRUG

Nexium

Interventions

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YYD601 1

Intervention Type DRUG

YYD601 2

Intervention Type DRUG

YYD601 3

Intervention Type DRUG

Nexium

Intervention Type DRUG

Eligibility Criteria

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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.