UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008206 |
|---|---|
| Receipt number | R000009635 |
| Scientific Title | The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects. |
| Date of disclosure of the study information | 2012/06/29 |
| Last modified on | 2016/04/09 12:04:41 |
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Basic information
Public title
The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects.
Acronym
Drug interaction study between Midazolam and short term Anchu-san multiple dose.
Scientific Title
The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects.
Scientific Title:Acronym
Drug interaction study between Midazolam and short term Anchu-san multiple dose.
Region
| Japan |
Condition
Condition
Japanese healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pilot study that previously conducted (UMIN ID:000006655) suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam (MDZ) dose. Therefore this study will be conducted to investigate the effects of the short term Anchu-san multiple dose (three times of 2.5g each) on the PK of oral administration of MDZ (7.5mg) in Japanese healthy male subjects. Short term Anchu-san repeated dose will be taken in two different groups that are allocated randomly. In G16 group, MDZ will be administered at 16 hours after the last Anchu-san dose. And MDZ administration will be performed at 2 hours after last Anchu-san in G2 group. The time effect of Anchu-san on MDZ PK in those 2 groups will also be investigated. In addition to these, the pharmacodynamic interaction between midazolam and Anchu-san will also be investigated.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The pharmacokinetics parameter of midazolam in serum (AUC 0-8), Cmax, t1/2, tmax)
Key secondary outcomes
1. The sedative action after midazolam oral administration: VAS
2. Safety assessment (pulse oximeter, vital measurement, adverse event)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Midazolam single oral administration at 2 hours after three times repeated dose of 2.5g Anchu-san
Interventions/Control_2
Midazolam single oral administration at 16 hours after three times repeated dose of 2.5g Anchu-san
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
| 25 | years-old | <= |
Age-upper limit
| 40 | 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
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Sanbe MD |
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
t-sambe@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Sanbe MD |
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
t-sambe@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
| 2012 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study was performed in 12 subjects. No adverse event was observed during the study in all subjects.
No pronounced differences on PK parameter of plasma Midazolam between pre- and post dose of Anch-san were observed in both G2 and G16 group.
No difference was also observed in VAS scale.
It was suggested that 1 day oral Anchu-san administration would not prominently affect on PK of oral Midazolam dose.
J. Showa Med Assoc.(in print)
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
| 2012 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | 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=R000009635
