Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers
NCT ID: NCT01787747
Last Updated: 2014-06-26
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
48 participants
INTERVENTIONAL
2012-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Cohorts A and C
Single dose (D1) followed by twice daily dosing for 7 days
AVP-786 Dose 1
AVP-923
Cohorts B and D
Single dose (D1) followed by twice daily dosing for 7 days
AVP-786 Dose 2
AVP-923
Cohorts E and F
Single dose (D1) followed by twice daily dosing for 7 days
AVP-786 Dose 1/Q Dose 1
AVP-923
Cohorts G and I
Single dose (D1) followed by twice daily dosing for 7 days
AVP-786 Dose 1/Q Dose 2
AVP-923
Cohorts H and J
Single dose (D1) followed by twice daily dosing for 7 days
AVP-786 Dose 2/Q Dose 2
AVP-923
Interventions
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AVP-786 Dose 1
AVP-786 Dose 2
AVP-786 Dose 1/Q Dose 1
AVP-786 Dose 1/Q Dose 2
AVP-786 Dose 2/Q Dose 2
AVP-923
Eligibility Criteria
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Inclusion Criteria
* 18 - 45 years of age
* BMI 18 - 30 kg/m2
Exclusion Criteria
* History of substance and/or alcohol abuse within the past 3 years
* Use of tobacco-containing or nicotine-contining products within 6 months
* Use of any prescription of over-the-counter (OTC) medication within 14 days
18 Years
45 Years
MALE
Yes
Sponsors
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Avanir Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sepehr Shakib, MD
Role: PRINCIPAL_INVESTIGATOR
CMAX
Locations
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CMAX
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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12-AVR-132
Identifier Type: -
Identifier Source: org_study_id
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