JPRN-UMIN000022061
Completed
未知
Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers - Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Clinical Trial Center, Kitasato University Hospital0 sites12 target enrollmentApril 26, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- those who are adapted Kampo formula which include Ephedra Herb
- Sponsor
- Clinical Trial Center, Kitasato University Hospital
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects will be excluded from the study by the following criteria. The investigator must ensure the criteria basically at the screening visit. 1\. Subjects who have a disease of the respiratory system, the digestive system, cardiovascular system, kidney, blood, psychoneurosis or cancer, or who had history of their disease. 2\. Subjects who have a surgical history of the digestive system or kidney. 3\. Subjects who have an infection of the respiratory system, skin, eye, the digestive system or urinary tract. 4\. Subjects who have a hypertension, hyperthyroidism or dysuria, or who had history of their disease. 5\. Subjects who have history of epileptic fit or organic insult to the brain and who have possibility of an epileptic seizure. 6\. Subjects who have an allergy to food and medicine or who had history of allergy. 7\. Subjects who have hay fever (allergic rhinitis). 8\. Subjects who smoke. 9\. Subjects who showed positive results of Syphilis test, Hepatitis B surface antigen or Hepatitis C. 10\. Subjects who had history of drug or alcohol abuse or who showed evidence of such abuse by the laboratory test at the screening. 11\. Subjects took any drug or health food containing St Johns wort within 4 weeks before dosing and be judged not eligible for the enrollment of the study by the investigator. 12\. Subjects who participated any clinical trials within 12 weeks before dosing of the first period. 13\. Subjects who donated 200ml of blood within 4 weeks or 400ml within 12 weeks. 14\. Subjects whom the investigator consider ineligible for the study.
Outcomes
Primary Outcomes
Not specified
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