UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006655 |
|---|---|
| Receipt number | 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 12:03:20 |
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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
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
nuchida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007759
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