Healthy male adult
Conditions
Interventions
Oral administration of the test drug (one time)
Oral administration of the standard drug (one time)
Sponsors
National Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese healthy male volunteers with 20 to 40 years of age when written informed consent is obtained. 2. Subjects with BMI of 18.5 and above to below 25.0 3. BMI (Body Mass Index) = body weight(kg)/height(m)2 (truncate the second decimal place and below) 4. Subjects who are judged as eligible in the screening test by the principal (or sub) investigator 5. Subjects who realize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with a disease under treatment 2. Subjects who are sensitive to drugs or have idiosyncrasy or the history of idiosyncrasy 3. Subjects with allergy disease such as bronchial asthma, pollenosis, atopic dermatitis etc. 4. Subjects who have diseases of heart, liver, kidney, digestive organs, respiratory organs and blood function or the history of the diseases or the severe operation history of the diseases and are judged as ineligible to participate in the study by the principal (or sub) doctor (excluding extirpation of appendicitis) 5. Subjects with remarkably weak stomach 6. Subjects with anorexia, nausea, vomiting 7. Subjects with tendency of remarkable sweating 8. Subjects with severe hypertension 9. Subjects with dysuria 10. Subjects with hyperthyroidism 11. Subjects with positive reaction in immunological serum testing or urine abuse test 12. Subjects who cannot keep no smoking in hospital and temperance from 2 days before hospitalization to leaving hospital 13. Subjects who used other drugs or took others drugs within one week before administration of the study drug or need to use other drugs or take other drugs in the first period 14. Subjects who participated in other clinical trials and received medication within 12 weeks before administration of the study drug in the first period 15. Subjects who donated 400 mL or 200 mL of blood within 12 or 4 weeks before administration of the study drug or have the schedule of donation of blood component (plasma or platelet) or donated the component within 2 weeks before administration of the study drug in the first period 16. 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 blood concentration of the representative components 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