UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030188 |
|---|---|
| Receipt number | R000034482 |
| Scientific Title | Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule) |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/06/05 18:58:21 |
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Basic information
Public title
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)
Acronym
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)
Scientific Title
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)
Scientific Title:Acronym
Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)
Region
| Japan |
Condition
Condition
Healty male adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
TSMURA Kakkonto extract granule and allocate Kakkonto tablet 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 representing the components of Kakkonto.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUCt and Cmax calculated from plasma concentration of ephedrine in test drug and standard drug
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Single oral administration of the test drug
Interventions/Control_2
Single oral administration of the standard drug
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
| 45 | years-old | > |
Gender
Male
Key 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
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hakamatsuka |
Organization
National Institute of Health Sciences
Division name
Division of Pharmacognosy, Phytochemistry and Narcotics
Zip code
210-9501
Address
3-25-26, Tonomachi,Kawasaki-ku, Kawasaki-shi,Kanagawa
TEL
044-270-6518
thakama@nih.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hakamatsuka |
Organization
National Institute of Health Sciences
Division name
Division of Pharmacognosy, Phytochemistry and Narcotics
Zip code
210-9501
Address
3-25-26, Tonomachi,Kawasaki-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-270-6518
Homepage URL
thakama@nih.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
Japan
Other related organizations
Co-sponsor
Tsumura & CO.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Health Sciences
Address
3-25-26, Tonomachi,Kawasaki-ku, Kawasaki-shi, Kanagawa-ken, Japan
Tel
044-270-6518
thakama@nih.go.jp
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 信濃会 信濃坂クリニック（東京都）（Shinanosazaka Clinic)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Published
Result
URL related to results and publications
The Japanese Journal of Pharmacognosy 74(2), 89-97 (2020).
Number of participants that the trial has enrolled
20
Results
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.
Results date posted
| 2021 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 07 | Day |
Baseline Characteristics
Japanese healthy male adult
Participant flow
The study was conducted as a two-group, two-period, and open-label crossover study in healthy Japanese volunteers.
Adverse events
Adverse events 5.0%(1/20)
A drug-related Adverse events:none
Outcome measures
The purpose of the present study was to investigate the potential to assess bioequivalence between kakkonto extract granules and tablets on the basis of the Guidelines for Bioequivalence Testing of Generic Drugs (partial revision, PFSB/ELD Notification No. 0229010 dated February 29, 2012).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 23 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034482
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