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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006655
Receipt No. R000007759
Scientific Title A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Date of disclosure of the study information 2011/11/10
Last modified on 2016/04/09

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Basic information
Public title A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Acronym Drug interaction study between Midazolam and Anchusan.
Scientific Title A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Scientific Title:Acronym Drug interaction study between Midazolam and Anchusan.
Region
Japan

Condition
Condition Japanese healthy male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a pilot study to investigate the effects of the 7 days Anchusan multiple dose (7.5g/day) on the pharmacokinetics of oral administration of midazolam (7.5mg) in Japanese healthy male subjects.
The pharmacodynamic interaction between midazolam and Anchusan will also be investigated by using both objective and subjective evaluation.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The pharmacokinetic parameters of plasma midazolam (AUC(0-10), Cmax, t1/2, tmax)
Key secondary outcomes 1. The sedative action after midazolam oral administration (subjective evaluation: VAS, objective evaluation: simple EEG measurement)
2. Safety assessment (pulse oximeter, vital measurement, adverse event)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 Midazolam single oral administration
Interventions/Control_2 Midazolam single oral administration after 7days Anchusan (7.5g/day) dose
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. Age: 20-45 years old at the time of informed consent
2. Sex: male
3. Subjects are competent to consent, keep the rules of the study and are able to report self condition.
4. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Key exclusion criteria 1. Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements).
2. Any history for drug allergy
3. Subjects who are taking in too much alcohol (those who cannot maintain the abstains from alcohol during study period).
4. Subjects within three months after the participation to other clinical trials
5. Subjects who are inadequate for enrollment judged by the investigator.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Uchida MD, PhD
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL 03-3784-8128
Email nuchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Uchida MD, PhD
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL 03-3784-8128
Homepage URL
Email nuchida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 昭和大学 臨床薬理研究センター(東京都)
Showa University Clinical Trial Center for Clinical Pharmacology (Tokyo)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 10 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
This pilot study was performed in two subjects. No adverse event was observed during the study in all subjects.
Mean value of PK parameter of plasma Midazolam are as follows;

Pre-dose of Anchu-san
Cmax:112.34 ng/mL, AUC:418.94 ng*hr/mL

After 7 days Anchu-san dose
Cmax:166.85 ng/mL, AUC:528.94 ng*hr/mL

No difference was observed in VAS scale between pre- and post- Anchu-san dose.

It was suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose.  The verification study will be conducted with increased number of study subjects.
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
2011 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 02 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007759

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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