Clinical trials: Pharmacokinetics of Mirabegron
Pharmacokinetics of YM178, Healthy Subjects
A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions
The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a…
- Trial name
- NCT01646294
- Testing
- YM178 modified release (OCAS), YM178 immediate release (IR)
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Renal Impairment
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
- Trial name
- NCT00750620
- Testing
- YM178
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex
Young and elderly, male and female subjects are each given 2 different doses of mirabegron for 7 days each. Levels of mirabegron in the blood are assessed.
- Trial name
- NCT01285596
- Testing
- Mirabegron
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Overactive Bladder, Pharmacokinetics
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined…
- Trial name
- NCT00856570
- Testing
- warfarin, YM178
- Where
- France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Plasma Concentration of Mirabegron
A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
- Trial name
- NCT01747564
- Testing
- YM178 (mirabegron)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
- Trial name
- NCT01297192
- Testing
- solifenacin succinate, mirabegron
- Where
- France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Neurogenic Detrusor Overactivity
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
- Trial name
- Crocodile (NCT02751931)
- Testing
- Mirabegron
- Where
- 32 sites in Australia, Belgium and 17 more
- Volunteers
- 91 people
- Sponsor
- Astellas Pharma Europe B.V.
Neurogenic Detrusor Overactivity, Overactive Bladder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.
- Conditions
- Neurogenic Detrusor Overactivity, Overactive Bladder, Pharmacokinetics of Mirabegron
- Trial name
- NCT02211846
- Testing
- Mirabegron
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 34 people
- Sponsor
- Astellas Pharma Inc
Healthy, Pharmacokinetics of Mirabegron
Study of the Effect of Food on the Pharmacokinetics of Mirabegron
The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.
- Trial name
- NCT00939757
- Testing
- mirabegron
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy, Pharmacokinetics of Mirabegron
Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron formulations with three different release rates versus three doses of mirabegron administered intravenously; to study safety and side…
- Trial name
- NCT00940121
- Testing
- mirabegron
- Where
- United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of Mirabegron and Tolterodine, Healthy
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine
To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites. In addition, the safety of these products will be assessed.
- Trial name
- NCT01964183
- Testing
- tolterodine, mirabegron
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc