UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026579 |
|---|---|
| Receipt number | R000030520 |
| Scientific Title | Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study |
| Date of disclosure of the study information | 2017/03/16 |
| Last modified on | 2020/03/22 16:21:16 |
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Basic information
Public title
Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study
Acronym
Pharmacokinetics of mianserin suppository in healthy volunteers
Scientific Title
Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study
Scientific Title:Acronym
Pharmacokinetics of mianserin suppository in healthy volunteers
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetics of a single rectal administration of mianserin 20 mg suppository in elderly healthy volunteers
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics parameters (area under the blood concentration time curve, maximum drug concentration, time of maximum drug concentration, half-life)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A single dose of mianserin 30 mg suppository will be rectally administered
Blood sampling will be conducted 7 times (at pre, 0.5, 1, 2, 4, 6, 8, 10, 24, 36, 48 hours).
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy volunteers enrolled this study must be agreement with the following criteria:
1. Age between 65 and 75
2. Male
3. Subjects are competent to consent, keep the rule of this study and are able to report self condition
4. Subjects who are judged eligible by the investigator in several series of medical check
Key exclusion criteria
1. Subjects who have inappropriate medical history (ex., drug abuse, alcoholism, any kind of heart, liver, kidney, lung, eye, blood diseases and digestive system disorder, etc.) or who are ingested medicines during this study.
2. Smoker.
3. Any drug allergy.
4. Subjects who are using excessive alcohol regularly (cannot keep abstinence for study period).
5. Participation in any clinical trial within the last 3 months.
6. Subjects who are inadequate for enrollment judged by the investigators.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Nawata |
Organization
Showa University
Division name
School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL
03-3784-8000
nawa_shu@cmed.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuchi |
| Middle name | |
| Last name | Nawata |
Organization
Showa University
Division name
School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL
03-3784-8000
Homepage URL
nawa_shu@cmed.showa-u.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmaceutics
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinical Research Institute for Clinical Pharmacology and Therapeutics
Showa University Karasuyama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address
6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel
03-3300-5231
scri@ofc.showa-u.ac.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
昭和大学附属烏山病院内 昭和大学臨床薬理研究所(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.showa-u.ac.jp/SUHK/guide/irb/report.html
Publication of results
Published
Result
URL related to results and publications
http://www.jscpt.jp/journal/pdf/j50_2.pdf
Number of participants that the trial has enrolled
3
Results
The effects of 20mg mianserin suppositories were evaluated in three healthy older male adults. Mianserin concentration in blood was measured using gas chromatography-mass spectrometry. tmax was 14.7(8.1)h; Cmax was 7.0
(1.4)ng mL; AUC0-48 was 196.7(19.6)h ng/mL
Results date posted
| 2020 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy older male adults
Participant flow
Open call for participants
Adverse events
no
Outcome measures
pharmacokinetics of mianserin suppositories
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2020 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030520
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