UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029799 |
|---|---|
| Receipt number | R000033931 |
| Scientific Title | Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product ) |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2018/02/01 11:58:47 |
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Basic information
Public title
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product )
Acronym
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product )
Scientific Title
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in Japanese healthy male volunteers (kakkonto decoction and its extract fine granule product )
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Hakamatsuka |
Organization
National Institute of Health Sciences
Division name
Division of Pharmacognosy, Phytochemistry and Narcotics
Zip code
Address
3-25-26, Tomomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-270-6518
thakama@nihs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Hakamatsuka |
Organization
National Institute of Health Sciences
Division name
Division of Pharmacognosy, Phytochemistry and Narcotics
Zip code
Address
3-25-26, Tomomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-270-6518
Homepage URL
thakama@nihs.go.jp
Sponsor or person
Institute
National Institute of Health Sciences
Division of Pharmacognosy, Phytochemistry and Narcotics
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033931
