Healthy VolunteersH-17-21NCT00716846
Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers
A study testing simvastatin, atorvastatin and pitavastatin in people with Healthy Volunteers, run by Hamamatsu University at 1 site in Japan.
Trial summary
The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- simvastatin, atorvastatin and pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteers in good health according to their medical history, a physical examination and standard laboratory tests
Who cannot join
- Subjects who have been using any continuous medication or herbal supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers
The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.
- Conditions
- Healthy Volunteers
- Being tested
- simvastatin, atorvastatin, pitavastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called Lipovas tablets
10mg, 2 weeks
atorvastatinDrug
Also called Lipitor tablets
10mg
pitavastatinDrug
Also called Livalo tablets
2mg
| Study group | Role | What they receive |
|---|---|---|
| statin-1 | Active comparator | simvastatin Receives: Drug: simvastatin |
| statin-2 | Active comparator | atorvastatin Receives: Drug: atorvastatin |
| statin-3 | Active comparator | pitavastatin Receives: Drug: pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pharmacokinetics of oral midazolam
Measured: after 14-days treatment with statins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoki Inui, Hamamatsu University
- Investigators
- Hiroshi Watanabe, MD,PhD, Study chair, Hamamatsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716846
- Sponsor's protocol ID
- Hamamatsu 18-21
- Acronym
- H-17-21
- Status last verified
- Mar 2009
- First submitted
- 10 Jul 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00716846
- Acronym / sponsor ID
- H-17-21 / Hamamatsu 18-21
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| statin-1 | Active comparator | Drug: simvastatinsimvastatin |
| statin-2 | Active comparator | Drug: atorvastatinatorvastatin |
| statin-3 | Active comparator | Drug: pitavastatinpitavastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers in good health according to their medical history, a physical examination and standard laboratory tests
Key exclusion criteria (1 listed)
- Subjects who have been using any continuous medication or herbal supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simvastatinAlso: Lipovas tablets10mg, 2 weeks | Drug | statin-1 |
| atorvastatinAlso: Lipitor tablets10mg | Drug | statin-2 |
| pitavastatinAlso: Livalo tablets2mg | Drug | statin-3 |
Primary outcome
the pharmacokinetics of oral midazolam
Time frame: after 14-days treatment with statins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Watanabe, MD,PhD study chair
Hamamatsu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simvastatin, atorvastatin and pitavastatin in people with Healthy Volunteers, run by Hamamatsu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pharmacokinetics of oral midazolam (time frame: after 14-days treatment with statins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011; AzTrials last refreshed its copy on 8 Nov 2026.