Healty male adult
Conditions
Interventions
Single oral administration of the test drug
Single oral administration of the standard drug
Sponsors
National Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics
Tsumura &
CO.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese subjects 2. Subjects with a BMI of 18.5-25 kg/m2 3. Subjects willing and able to provide written and signed informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt and Cmax calculated from plasma concentration of ephedrine in test drug and standard drug | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakashi Hakamatsuka
National Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics
Outcome results
None listed