Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
NCT ID: NCT01039194
Last Updated: 2011-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2010-01-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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galantamine 8 mg (ER)
galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
galantamine 16 mg (ER)
galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
BMS-708163
BMS-708163
Capsule, Oral, 125 mg, once daily, Days 15-24
Interventions
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galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
BMS-708163
Capsule, Oral, 125 mg, once daily, Days 15-24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bleeding disorders
* Peptic ulcer disease
* Cholecystectomy
* Seizure disorder
* Asthma
* Chronic obstructive pulmonary disease
* Urinary tract obstruction
* Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
18 Years
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Parexel International - Baltimore Epcu
Baltimore, Maryland, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CN156-009
Identifier Type: -
Identifier Source: org_study_id
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