MedDataX Logo

A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

NCT ID: NCT02010944

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phase 1 Bioavailability Healthy Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Solifenacin Mirabegron Fixed-dose combination (FDC) Single Entity Tablet (SET) Pharmacokinetics Bioavailability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: FDC-SET-SET

Fixed Dose Combination followed by two periods of the Single Entity Tablets

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

oral

mirabegron

Intervention Type DRUG

oral

mirabegron/solifenacin succinate

Intervention Type DRUG

oral

2: SET-FDC-FDC

Single Entity Tablets followed by two periods of Fixed Dose Combination

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

oral

mirabegron

Intervention Type DRUG

oral

mirabegron/solifenacin succinate

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

solifenacin succinate

oral

Intervention Type DRUG

mirabegron

oral

Intervention Type DRUG

mirabegron/solifenacin succinate

oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vesicare®, YM905 YM178 YM178/YM905

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Parexel

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-002650-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-103

Identifier Type: -

Identifier Source: org_study_id