None listed
Conditions
Interventions
Drug : Part A: At 1 period oral administration of Pyungwi-san Extract powder(dose:Once per 2.5g),At 2 period oral administration of Pyungwi-san soft extract(dose:Once per 9.81g)
Part B: At 1 period o
Sponsors
Ministry of Health & Welfare
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male Korean subject age 19 to 55 at the screening visit 2) Subject who is over 55kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20% * IBW (Ideal body weight)(kg) = {height(cm) - 100} * 0.9 3) Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination(if necessary,EEG,chest and upper gastrointestinal endoscopy or radiography), subject who is no pathological symptoms or findings 4)Acupuncturist is set according to the characteristics of medicines and conducted blood tests pathology, blood chemistry, urinalysis test results, including clinical pathology clinical judged fit to test subjects 5) After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trial and agreed to observe notice
Exclusion criteria
Exclusion criteria: 1)A person who has taken liver, kidneys, nervous system, immune system, respiratory, musculoskeletal disease or blood available and the endocrine system and cancer diseases, cardiovascular diseases, mental disorders (mood disorders, obsessive compulsive disorder, etc.) who have a history or are(In the case of liver disease item, or hepatitis B antigen, including one who shows a hepatitis C antibody positive). In particular,A person who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 2)A person who has taken gastrointestinal diseases (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) and a history of gastrointestinal surgery (where the simple appendectomy or hernia operation is excluded) 3) A person who had some lab data below. After the break in the sitting position measured vital signs,systolic blood pressure = 90 mmHg or = 160 mmHg or diastolic blood pressure = 60 mmHg or = 100 mmHg 4)A person who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital. (10% wine 125mL = 12.5g, 3% beer 250mL = 7.5g, 6% beer 250mL = 15g, 20% Suzhou 50mL = 10g, 6% 300mL = 18g rice wine, etc.) 5)A person who has taken xanthine continuously (coffee, tea, cola more than 4 cups per a day) 6)A person who smoked more than 20 piece of tobacco/day or can't stop smoking from on the day of blood collection period 7)A person who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the last 30 days. 8)A person who has medical history of drug abuse or misuse (Amphetamine,barbiturates, cocaine, opioids, benzodiazepines, etc.) 9) A person who has taken other prescription medicine or oriental drugs within the last 30 days, or Over the Prescription drugs within the last 14 days ,or Over the generic drugs within the last 10 days 10) A person who had enrolled to participated in different bioequivalence studies or other clinical trial within the last 90 days. 11)A person who can't take a meal derived from this trial. 12)A person who is determined to be unsuitable about participation in clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured density of component indicator in extracted plasma at sampling time. And compute the area of under the “density of component indicator in blood - time“ curve. | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Yang
Dongshin University
Outcome results
None listed