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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029232
Receipt No. R000033339
Scientific Title Effects of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Volunteers
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/06

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Basic information
Public title Effects of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Volunteers
Acronym Effects of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Volunteers
Scientific Title Effects of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Volunteers
Scientific Title:Acronym Effects of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Volunteers
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the efficacy and safety of digoxin on rosuvastatin pharmacokinetics at a single-center open-label study in Japanese healthy male volunteers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Compared between a rosuvastatin alone and rosuvastatin with digoxin by means of the geometric mean ratio (GMR) AUC (0-last) and its 90% confidence interval (CI).
Key secondary outcomes 1) Cmax and GMR (AUC (0-inf)) and its 90% CI
2) Pharmacokinetic parameter (Cmax, tmax, t1/2, AUC0-inf, AUC0-last, CL/F, Vd/F)
3) Plasma concentration of rosuvastatin in transition

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Rosuvastatin 5mg is administered once on Day 1 of Phase 1 and Day 1 of Phase 2 Study
Interventions/Control_2 Digoxin 0,25mg on Day 1 of the Phase 2 study.
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) Subjects who are aged between 20 and 45 (exclusive) years old, at the time of Informed Consent.
2) Subjects who have a BMI (Body Mass Index) between 18.5 and 28.0 (exclusive).
Key exclusion criteria 1) Have a history of drug abuse or alcohol addiction or a history of allergies to any medication.
2) Have a history of hypersensitivity to rosuvastatin or digoxin .
3) Have a disease which may affect drug evaluation, a history of invasive therapy or radiation therapy.
4) Have taken the drugs, foods or drinks containing methylxanthine such as caffeine (coffee, tea, cola drinks, chocolate, etc) for 48 hours before testing.
5) Have taken any foods or drinks containing grapefruit juice, grapefruit, St. John's wort or Seville orange for 48 hours before testing.
6) Smoke (including those who take nicotine - containing products). However, those who stop smoking (unused period of nicotine-containing products) over 24 weeks are excluded.
7) Drink any beverage containing alcohol for 1 weeks before testing.
8) Conducted intense exercise or hard labor (more than 1 day a day for more than 5 days a week).
9) Have a history of drug abuse or alcohol addiction.
10) Use any medical drugs for 4 weeks before testing.
11) Treated with OTC, nutrients, vitamins, herbal preparations (including traditional Chinese medicine) for 1 weeks before testing.
12) Subjects are not currently enrolled in a clinical trial involving an investigational drug or device, or had not been enrolled in any other medical research for 16 weeks before testing.
13) Fall under any of the following:
a) Received blood transfusion within 12 weeks before testing.
b) Donated more than 400 mL of blood within 12 weeks before testing.
c) Donated more than 200 mL of blood within 4 weeks before testing.
d) Donated component blood donation within 2 weeks before testing.
14) Have a history of infectious diseases requiring urgent treatment.
15) Have a positive result for Human Immunodeficiency Virus (HIV) test, hepatitis B or C antigen test or syphilis test.
16) Subjects determined by the investigators to be inadequate for inclusion in this study for any other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Uemura
Organization Oita University Hospital
Division name Clinical Pharmacology Center
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Email uemura@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Uemura
Organization Oita University Hospital
Division name Clinical Pharmacology Center
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Homepage URL
Email uemura@oita-u.ac.jp

Sponsor
Institute Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Seren Pharmaceuticals Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Sato Pharmaceutical Co.
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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
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
2019 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033339

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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