Clinical trial NCT03558477: PK/PD Clinical Trial of YYD601 in Healthy Adult Male
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each arm is assignted 10 persons\[the percent of each arm is (treatmnet: comparator=4:1)\]
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: half-life
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Tmax
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Concentration
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: AUC
timeFrame: Evaluate the before/after treatment period(5 days per phase)
Secondary outcomes:
measure: Percent of pH>4 duration time
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: % change in serum gastrin level
timeFrame: Evaluate the before/after treatment period(5 days per phase)
Other outcomes:
measure: Adverse event monitoring check up the adverse events
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature)
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Adverse event monitoring check up the 12-lead EKG
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Adverse event monitoring check up the clinical laboratory test
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Adverse event monitoring check up the physical
timeFrame: Evaluate the before/after treatment period(5 days per phase)
measure: Adverse event monitoring check up the administraton about the combined drugs
timeFrame: Evaluate the before/after treatment period(5 days per phase)
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
References:
citation: 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.