PK/PD Clinical Trial of YYD601 in Healthy Adult Male

Phase 1

Completed

• Conditions: GERD
• Interventions: Drug: YYD601 3; Drug: YYD601 1; Drug: YYD601 2; Drug: Nexium

• Registration Number: NCT03558477
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-09-19
• Study First Submitted: 2017-10-11
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-07
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-04
• Last Update Submitted: 2018-06-04
• Study First Posted: 2018-06-15
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Set 3(YYD601 3 & Nexium)	YYD601 3	Set 3:YYD601 3 \& Nexium
Set 1(YYD601 1 & Nexium)	YYD601 1	Set 1: YYD601 1 \& Nexium
Set 2(YYD601 2 & Nexium)	YYD601 2	Set 2: YYD601 2 \& Nexium
Set 1(YYD601 1 & Nexium)	Nexium	Set 1: YYD601 1 \& Nexium
Set 2(YYD601 2 & Nexium)	Nexium	Set 2: YYD601 2 \& Nexium
Set 3(YYD601 3 & Nexium)	Nexium	Set 3:YYD601 3 \& Nexium

Primary Outcome Measures

Name	Time	Method
half-life	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)
Tmax	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)
Concentration	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)
AUC	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 Outcome Measures

Name	Time	Method
Percent of pH>4 duration time	Evaluate the before/after treatment period(5 days per phase)	pH\>4 duration time
% change in serum gastrin level	Evaluate the before/after treatment period(5 days per phase)	serum gastrin level

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Korea, Republic of