An Open-label, Parallel, Single-Dose, Clinical Study after administration of WS1313D in Children and Adolescent with Pain to Evaluate Pharmacokinetics (PK) / Pharmacodynamics (PD) and Safety
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0004166
- Lead Sponsor
- Woosung Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 62
The subjects to be enrolled in this study should satisfy all of the following criteria.
1) Age and weight: Children From about 2 years old to under 11 years old and weighing from 10 kg to less than 33 kg. Or adolescents who are between about 11 years old and under 19 years old and weigh more than 33 kg but less than 50 kg. However, age is only a reference item, and when the age and weight range do not match, the investigator will decide whether or not to select the weight based on the weight.
2) Admission status: Those who were admitted to the hospital from the time of screening, who are scheduled to be admitted during the clinical trial period, or who are scheduled to be admitted to the hospital on the scheduled date of administration of the clinical trial drug.
3) Disease: Those who are expected to need medication due to moderate pain.
4) IV: Severe nausea / nausea or vomiting symptoms that lead to an NPO (nothing by mouth). Or those who are expected to require IV administration due to scheduled surgery, such as those who need intravenous or rapid intravenous administration at the discretion of the investigator.
5) Those who can participate in the entire period of this clinical trial.
6) If the subject's volunteer voluntarily signs a written ICF(Informed Consent Form) to participate in the subject's clinical trial (including signature of the subject's participation in clinical trials if possible)
The subjects to be enrolled in this trial are excluded if any of the following criteria are met.
1) Those who can not collect blood of up to 7 mL / kg per day required by this clinical trial.
2) Those who have hypersensitivity to the active ingredient or additive of the clinical trial drug.
3) Within 24 hours prior to administration of the clinical trial drug and within 12 hours of the screening time, the drug containing acetaminophen (acetaminophen or paracetamol) or propacetamol was administered, or the drug containing probenecid or isoniazide was administered within 48 hours If you have received medication containing disulfiram within one month
4) A patient with severe hepatic impairment or total bilirubin is measured at 1.5 times the normal upper limit of the clinical laboratory or the ALT or AST is 2.5 times the normal upper limit of the clinical laboratory.
5) Patients with severe renal impairment or eGFR (Estimated glomerular filtration rate) less than 1/3 of the normal lower limit of clinical laboratory.
6) For pregnant or lactating women, or as a child of childbearing age, medically accepted methods of contraception from the screening date of the trial to the 30th day after the last dose of the clinical trial drug, either not agreeing to use at least two of the following contraceptive methods, Those who disagree
- Medicines: Oral contraceptives, skin patches or progestins (implants or injections)
- Diaphragmatic method: condom, diaphragm, intrauterine device (IUD), vaginal suppository
- Abstinence: Absolute abstinence (except periodical abstinence (eg calendars, ovulation, symptom thermotherapy) and abstinence are not considered contraceptive methods.)
7) Those who participated in other clinical trials within 90 days of screening
8) Patients with peptic ulcer
9) Patients with severe blood disorders
10) Patients with severe hepatic impairment
11) Patients with severe renal impairment
12) Patients with severe cardiac dysfunction
13) Patients with aspirin asthma (asthma attacks caused by non-steroidal anti-inflammatory drugs)
14) Patients taking the following drugs: barbiturates, tricyclic antidepressants
15) Patients taking the drug within 48 hours after administration of the drug for clinical trial
16) Those who are diagnosed as not being able to participate in the clinical trial according to the judgment of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The peak blood concentration (Cmax) after administration of the drug for clinical trials.;AUC from 0 h prior to administration of the drug for clinical trial to 6 h after administration
- Secondary Outcome Measures
Name Time Method Percentage of patients with a pain score of at least 2 points before the administration of the investigational products and within 6 hours of the completion of the study.;Percent reduction of pain scores before and 30 minutes, 1, 2, and 6 hours after administration of the investigational products for clinical trial.;Blood concentration and pain score tendency of acetaminophen before and after drug administration for investigational products.;Body temperature reduction rate before administration of investigational products for clinical trial and after 30 minutes, 1, 2 and 6 hours after administration;Blood concentration and body temperature tendency of acetaminophen before and after administration of medication for investigational products.