A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501267
First received: July 13, 2007
Last updated: October 9, 2008
Last verified: October 2008
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The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder |
Drug: solabegron and oxybutynin |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Absorption rate of solabegron and oxybutynin [ Time Frame: as measured by multiple blood draws after repeat dosing ]
Secondary Outcome Measures:
- To assess bladder function [ Time Frame: prior to dosing Session 1 and post dose for each session ]
Enrollment: | 24 |
Study Start Date: | June 2007 |
Intervention Details:
-
Drug: solabegron and oxybutynin
Other Name: solabegron and oxybutynin
![](https://webarchive.library.unt.edu/web/20121019083141im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adult males & females ages 18-65;
- Body weight >50kg; BMI between 19-32;
- Signed and dated informed consent; QTc Interval <450 msec;
Exclusion Criteria:
- Resting blood pressure >140/90 mmHg or HR >100 at screening;
- History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
- Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
- Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
- history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
- history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
- clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigatorâ s assessment
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No publications provided
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00501267 History of Changes |
Other Study ID Numbers: | B3C109868 |
Study First Received: | July 13, 2007 |
Last Updated: | October 9, 2008 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
solabegron, oxybutynin, healthy adults, drug interaction |
Additional relevant MeSH terms:
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Oxybutynin Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012