GERD
Conditions
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.
Interventions
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each arm is assignted 10 persons\[the percent of each arm is (treatmnet: comparator=4:1)\]
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| % change in serum gastrin level | Evaluate the before/after treatment period(5 days per phase) | serum gastrin level |
| Percent of pH>4 duration time | Evaluate the before/after treatment period(5 days per phase) | pH\>4 duration time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event monitoring check up the clinical laboratory test | Evaluate the before/after treatment period(5 days per phase) | clinical laboratory test |
| Adverse event monitoring check up the physical | Evaluate the before/after treatment period(5 days per phase) | physical |
| Adverse event monitoring check up the administraton about the combined drugs | Evaluate the before/after treatment period(5 days per phase) | administraton about the combined drugs |
| Adverse event monitoring check up the adverse events | Evaluate the before/after treatment period(5 days per phase) | Adverse events |
| Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature) | Evaluate the before/after treatment period(5 days per phase) | vital sign(blood-pressure, pulse rate, temparature) |
| Adverse event monitoring check up the 12-lead EKG | Evaluate the before/after treatment period(5 days per phase) | 12-lead EKG |
Countries
South Korea
Outcome results
None listed