PK/PD Clinical Trial of YYD601 in Healthy Adult Male

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)

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: YYD601 1; Drug: Nexium; Drug: YYD601 2; Drug: YYD601 3

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Set 1(YYD601 1 & Nexium); Set 1: YYD601 1 & Nexium	Drug: YYD601 1; YYD601 1; Drug: Nexium; Nexium
EXPERIMENTAL: Set 2(YYD601 2 & Nexium); Set 2: YYD601 2 & Nexium	Drug: Nexium; Nexium; Drug: YYD601 2; YYD601 2
EXPERIMENTAL: Set 3(YYD601 3 & Nexium); Set 3:YYD601 3 & Nexium	Drug: Nexium; Nexium; Drug: YYD601 3; YYD601 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
half-life	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)	Evaluate the before/after treatment period(5 days per phase)
Tmax	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)	Evaluate the before/after treatment period(5 days per phase)
Concentration	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)	Evaluate the before/after treatment period(5 days per phase)
AUC	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)	Evaluate the before/after treatment period(5 days per phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of pH>4 duration time	pH>4 duration time	Evaluate the before/after treatment period(5 days per phase)
% change in serum gastrin level	serum gastrin level	Evaluate the before/after treatment period(5 days per phase)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event monitoring check up the adverse events	Adverse events	Evaluate the before/after treatment period(5 days per phase)
Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature)	vital sign(blood-pressure, pulse rate, temparature)	Evaluate the before/after treatment period(5 days per phase)
Adverse event monitoring check up the 12-lead EKG	12-lead EKG	Evaluate the before/after treatment period(5 days per phase)
Adverse event monitoring check up the clinical laboratory test	clinical laboratory test	Evaluate the before/after treatment period(5 days per phase)
Adverse event monitoring check up the physical	physical	Evaluate the before/after treatment period(5 days per phase)
Adverse event monitoring check up the administraton about the combined drugs	administraton about the combined drugs	Evaluate the before/after treatment period(5 days per phase)

Collaborators and Investigators

• Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and Pharmacodynamics of YYD601, a Dual Delayed-Release Formulation of Esomeprazole, Following Single and Multiple Doses in Healthy Adult Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2022 Mar 6;16:619-634. doi: 10.2147/DDDT.S338131. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2017
• Primary Completion (ACTUAL): February 7, 2018
• Study Completion (ACTUAL): February 7, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: YYPCT_YYD601_P1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No