Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 20, 2010

Primary Completion Date

August 14, 2011

Study Completion Date

August 14, 2011

Conditions
Urinary Bladder, Overactive
Interventions
DRUG

Solifenacin succinate suspension 2.5 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.

DRUG

Solifenacin succinate suspension 5 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.

DRUG

Solifenacin succinate suspension 10 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.

Trial Locations (8)

8200

Aarhus

8500

Kortrijk

9000

Ghent

41685

Gothenburg

75185

Uppsala

CB2 2QQ

Cambridge

M13 9WL

Manchester

S10 2TH

Sheffield

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY