Clinical TrialID 5340
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects
NCT02169713
Healthy Subjects|Pharmacokinetics|Drug-Drug Interaction (DDI)
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5340
- Evidence Id
- 5340
- Core Evidence Id
- 5340
- Source Clinical Trial Id
- 5326
- Herb2 Clinical Trial Id
- HBCT005326
- Nct Id
- NCT02169713
- Title
- Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Healthy Subjects|Pharmacokinetics|Drug-Drug Interaction (DDI)
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Mirabegron|DRUG: Solifenacin succinate|DRUG: Tamsulosin HCl|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Double
- Intervention Purpose
- Basic_Science
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 20
- Outcome Measure
- Pharmacokinetic parameter for tamsulosin HCl (plasma) in the absence and presence of solifenacin and mirabegron: Cmax, Maximum concentration (Cmax), Day 14 in each investigational period|Pharmacokinetic parameter for tamsulosin HCl (plasma) in the absence and presence of solifenacin and mirabegron: AUCtau, Area under the curve over a dosing interval (AUCtau), Day 14 in each investigational period
- Sponsor Collaborator
- Astellas Pharma Europe B.V.
- Funded By
- INDUSTRY
- Location
- Parexel International GmbH, Berlin, 14050, Germany
- Other Id
- 178-CL-109|2013-004230-15
- Start Date
- 2014-05
- Primary Completion Date
- 2014-08
- Completion Date
- 2014-08
- First Posted
- 2014-06-23
- Results First Posted
- Last Update Posted
- 2014-08-29
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02169713
- Title Cn
- Title En
- Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects
- Bilingual Status
- semi_complete