PK/PD Clinical Trial of YYD601 in Healthy Adult Male

YooYoung Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: YYD601 1; Drug: YYD601 2; Drug: Nexium; Drug: YYD601 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT03558477

YYPCT_YYD601_P1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Set 1(YYD601 1 & Nexium)

Experimental group

Description:

Set 1: YYD601 1 \& Nexium

Treatment:

Drug: Nexium

Drug: YYD601 1

Set 2(YYD601 2 & Nexium)

Experimental group

Description:

Set 2: YYD601 2 \& Nexium

Treatment:

Drug: Nexium

Drug: YYD601 2

Set 3(YYD601 3 & Nexium)

Experimental group

Description:

Set 3:YYD601 3 \& Nexium

Treatment:

Drug: Nexium

Drug: YYD601 3