UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product )
Title of the study (Brief title)	Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product )
Region	Japan

Condition
Condition	Healthy male adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Allocate kakkonto decoction and Kuracie kakkonto extract fine granule product to standard and test drug and confirm the bio-equivalence in the components by comparison of blood pharmacokinetic parameters between the standard drug and the test drug in the indices of ephedrine, pseudoephedrine etc. representing the components of kakkonto.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AUCt and Cmax calculated from blood concentration of the representative components in test drug and standard drug
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of the test drug (one time)
Interventions/Control_2	Oral administration of the standard drug (one time)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key 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
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Hakamatsuka
Organization	National Institute of Health Sciences
Division name	Division of Pharmacognosy, Phytochemistry and Narcotics
Address	3-25-26, Tomomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-270-6518
Email	thakama@nihs.go.jp

Public contact
Name of contact person	Takashi Hakamatsuka
Organization	National Institute of Health Sciences
Division name	Division of Pharmacognosy, Phytochemistry and Narcotics
Address	3-25-26, Tomomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-270-6518
Homepage URL
Email	thakama@nihs.go.jp

Sponsor
Institute	National Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団 盟生会 東新宿クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033931