PK/PD Clinical Trial of YYD601 in Healthy Adult Male

NCT03558477 | Completed Phase 1

• 1 other identifier: YYPCT_YYD601_P1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Percent of pH>4 duration time

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

• % change in serum gastrin level

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

Other Outcomes (6)

• Adverse event monitoring check up the 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)

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

• Adverse event monitoring check up the 12-lead EKG

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

Study Arms (3)

Set 1(YYD601 1 & Nexium)

EXPERIMENTAL

Set 1: YYD601 1 \& Nexium

Drug: YYD601 1; Drug: Nexium

Set 2(YYD601 2 & Nexium)

EXPERIMENTAL

Set 2: YYD601 2 \& Nexium

Drug: YYD601 2; Drug: Nexium

Set 3(YYD601 3 & Nexium)

EXPERIMENTAL

Set 3:YYD601 3 \& Nexium

Drug: YYD601 3; Drug: Nexium

Interventions

YYD601 1 DRUG

YYD601 1

Set 1(YYD601 1 & Nexium)

YYD601 2 DRUG

YYD601 2

Set 2(YYD601 2 & Nexium)

YYD601 3 DRUG

YYD601 3

Set 3(YYD601 3 & Nexium)

Nexium DRUG

Nexium

Set 1(YYD601 1 & Nexium); Set 2(YYD601 2 & Nexium); Set 3(YYD601 3 & Nexium)

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: healthy adult male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Kyungpook national university hospital

Daegu, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35281316 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: June 15, 2018
• Study Start: September 19, 2017
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

KR (1)