Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)
- Conditions
- Healty male adult
- Registration Number
- JPRN-UMIN000030188
- Lead Sponsor
- ational Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics
- Brief Summary
The Japanese Journal of Pharmacognosy 74(2), 89-97 (2020). Our results suggest that the marker compounds exhibiting similar in pharmacokinetic parameters following the administration of Kampo extract granules and the corresponding standard decoction could be applied as markers for the evaluation of bioequivalence between already-approved Kampo extract granules and novel Kampo products based on the same extract as that of granules.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Not provided
1. Subjects of less than 50 kilograms of body weight 2. Subjects with a history of allergic reactions to drugs and food(s) 3. Subjects who have participated in another clinical study within the past 16 weeks 4. Subjects who have had their blood drawn or who have donated 400 mL of blood within 12 weeks of study drug administration 5. Subjects with a history of a significant hepatic or respiratory disease 6. Subjects with a history of gastrointestinal disease (peptic ulcer, esophageal reflux) etc. except appendicitis 7. Subject with a history of digestive treat resection (except for appendicitis) 8. Subjects who are not able to stop smoking or drinking from the hospitalization day until completion of each treatment phase of the study 9. Subjects who are not able to stop taking medications and supplements during this trial 10. Subject who are judged inappropriate by the principal (or sub) doctor because the results of the screening test or 1st hospitalization day's test have deviated from the reference range 12. Subjects who are judged as ineligible to participate in the study for other reasons by the principal (or sub) doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt and Cmax calculated from plasma concentration of ephedrine in test drug and standard drug
- Secondary Outcome Measures
Name Time Method AUCt and Cmax calculated from plasma concentration of pseudoephedrine in test drug and standard drug Plasma concentration, AUCinf, MRTinf, tmax, and Cmax,rambdaz of ephedrine and pseudoephedrine in test drug and standard drug