UMIN-CTR Clinical Trial

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
Email	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
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	National Institute of Health Sciences
Address	3-25-26, Tonomachi,Kawasaki-ku, Kawasaki-shi, Kanagawa-ken, Japan
Tel	044-270-6518
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034482