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Clinical research of atorvastatin to evaluate the effect of OATP2B1 inhibition and drug-drug interaction

Clinical research of atorvastatin to evaluate the effect of OATP2B1 inhibition and drug-drug interaction - Clinical research of atorvastatin and OATP2B1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009480
Enrollment
24
Registered
2012-12-05
Start date
2013-01-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy male and female

Interventions

substrate cocktail, wash out, with atorvastatin, wash out, with grapefruit juice

Sponsors

Department of clinical pharmacokinetics, Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The investigators must ensure that all subjects being considered meet the following inclusion criteria: 1) Japanese healthy male or female who is capable to understand and sign the informed consent 2) 20-45 years of age 3) BMI 17.6-26.4 4) good health as determined by physical examination, vital signs and laboratory tests.

Exclusion criteria

Exclusion criteria: The investigators must ensure that all subjects being considered 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 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4) donation of 400 mL or more of blood within 12 (male) or 16 (female) 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 8) lactose intolerance.

Design outcomes

Primary

MeasureTime frame
PK profiles of rosuvastatin, celiprolol, salazosulfapyridine, sumatriptan, glibenclamide and atorvastatin

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026