ITCMDBv1
Clinical TrialID 5341

EC905 Pharmacokinetic Profile Study

NCT02634489

Phase 1|Healthy|Benign Prostatic Hyperplasia|Lower Urinary Tract Symptoms

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
5341
Evidence Id
5341
Core Evidence Id
5341
Source Clinical Trial Id
5327
Herb2 Clinical Trial Id
HBCT005327
Nct Id
NCT02634489
Title
EC905 Pharmacokinetic Profile Study
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Phase 1|Healthy|Benign Prostatic Hyperplasia|Lower Urinary Tract Symptoms
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Intervention
DRUG: Tamsulosin HCl|DRUG: Solifenacin Succinate|DRUG: EC905
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Intervention Purpose
Basic_Science
Gender
Male
Age
Adult, Older_Adult
Enrollment
46
Outcome Measure
Pharmacokinetics (PK) of tamsulosin HCl and solifenacin succinate in plasma: AUCtau, AUCtau: area under the concentration - time curve (AUC) during the time interval between consecutive dosing, Day 12|PK of tamsulosin HCl and solifenacin succinate in plasma: Cmax, Cmax: maximum concentration, Day 12
Sponsor Collaborator
Astellas Pharma Europe B.V.
Funded By
INDUSTRY
Location
Site NL1, Zuidlaren, Drente, 9471 GP, Netherlands
Other Id
905-CL-071|2007-005155-41
Start Date
2009-03
Primary Completion Date
2009-07
Completion Date
2009-07
First Posted
2015-12-18
Results First Posted
Last Update Posted
2015-12-18
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02634489
Title Cn
Title En
EC905 Pharmacokinetic Profile Study
Bilingual Status
semi_complete