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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02010944
Other study ID # 178-CL-103
Secondary ID 2012-002650-23
Status Completed
Phase Phase 1
First received October 4, 2013
Last updated December 10, 2013
Start date September 2012
Est. completion date November 2012

Study information

Verified date October 2013
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.


Description:

There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.

The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.

Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.

Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.

An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Male subject must agree to not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.

- Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.

Exclusion Criteria:

- Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.

- Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.

- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.

- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
solifenacin succinate
oral
mirabegron
oral
mirabegron/solifenacin succinate
oral

Locations

Country Name City State
Germany Parexel Berlin

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameter of solifenacin in plasma as measured by Cmax (Maximum concentration) Days 1-11 No
Primary Pharmacokinetic parameter of solifenacin in plasma as measured by AUClast (AUC until last sample taken) Days 1-11 No
Primary Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity) Days 1-11 No
Primary Pharmacokinetic parameter of mirabegron in plasma as measured by Cmax (Maximum concentration) Days 1-11 No
Primary Pharmacokinetic parameter of mirabegron in plasma as measured by AUClast (AUC until last sample taken) Days 1-11 No
Primary Pharmacokinetic parameter of mirabegron in plasma as measured by AUCinf (AUC extrapolated until infinity) Days 1-11 No
Secondary Pharmacokinetic profile of Solifenacin in plasma AUC0-72h (Area under the plasma concentration-time curve from time zero to 72h), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance) Days 1-11 No
Secondary Pharmacokinetic profile of mirabegron in plasma AUC0-72h (Area under the plasma concentration-time curve from time zero to 72h), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance) Days 1-11 No
Secondary Safety and tolerability of solifenacin succinate and mirabegron assessed by adverse events, vital signs, laboratory tests, physical examination and 12-lead electrocardiogram (ECG) Screening to End of Study Visit (Day 11 Period 3 or within 7 to 14 days after discontinuation) No
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