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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000002714 |
Receipt No. | R000003308 |
Scientific Title | Clinical research of celiprolol, fexofenadine, atenolol cocktail-microdose to validate the utility of microdose study on the drug transporter SNP's |
Date of disclosure of the study information | 2010/10/03 |
Last modified on | 2010/10/03 |
Basic information | ||
Public title | Clinical research of celiprolol, fexofenadine, atenolol cocktail-microdose to validate the utility of microdose study on the drug transporter SNP's | |
Acronym | celiprolol cocktail-microdose | |
Scientific Title | Clinical research of celiprolol, fexofenadine, atenolol cocktail-microdose to validate the utility of microdose study on the drug transporter SNP's | |
Scientific Title:Acronym | celiprolol cocktail-microdose | |
Region |
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Condition | ||
Condition | healthy male | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate PK profiles of cocktail-dose of celiprolol, fexofenadine and atenolol, and to assess inhibitory effect of grapefruit juice on celiprolol PK, then to identify the relationship between PK profiles and regarded genes. |
Basic objectives2 | Pharmacokinetics |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | PK profiles of celiprolol, fexofenadine and atenolol |
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 |
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Interventions/Control_1 | celiprolol, fexofenadine, atenolo and grapefruit juice | ||
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 |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | the investigors must ensure that all subjects
being considerd meet the following inclusion criteria: 1) Japanese healthy male who is capable to understand and sign the informed consent. 2) 20-45 years of age 3)BMI 18.5-25.0 4)good health as determined by physical examination, vital signs and laboartory tests. |
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Key exclusion criteria | the investigors must ensure that all subjects
being considerd meet the following exclusion criteria or conditions: 1)history of allergy to any drugs 2)medical attention within 2 months prior to participation 3)donation of 200mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4)donation of 400mL or more of blood within 12 weeks prior to participation 5)recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6)history of drug abuse 7)alcohol abuse |
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Target sample size | 42 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | LTA | ||||||
Division name | Kyusyu Clinical Pharmacology Clinic | ||||||
Zip code | |||||||
Address | 2-13-16 Chigyo Fukuoka | ||||||
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Name of contact person |
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Organization | LTA | ||||||
Division name | Kyusyu Clinical Pharmacology Clinic | ||||||
Zip code | |||||||
Address | |||||||
TEL | 092-733-1001 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | APDD |
Institute | |
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Funding Source | |
Organization | APDD |
Organization | |
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IRB Contact (For public release) | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003308 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |