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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030188
Receipt No. 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 2018/06/01

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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
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, Tonomachi,Kawasaki-ku, Kawasaki-shi,Kanagawa
TEL 044-270-6518
Email thakama@nih.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, Tonomachi,Kawasaki-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL 044-270-6518
Homepage URL
Email thakama@nih.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 Japan

Other related organizations
Co-sponsor Tsumura & CO.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 25 Day
Date of IRB
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
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2018 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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