A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
NCT ID: NCT02465866
Last Updated: 2017-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2014-11-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A: CL-108 (Fasted)
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
Treatment B: CL-108 (Fed)
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
CL-108
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen
Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
Ultracet
Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
Phenergan
Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Vicoprofen
Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
Ultracet
Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
Phenergan
Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
Interventions
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CL-108
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
Vicoprofen
Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
Ultracet
Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
Phenergan
Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
* Abide by study restrictions
* Acceptable birth control measures
* Ability to attend all study visits
* Vital signs as per protocol
* Willing to consume high calorie meals within designated time frame
Exclusion Criteria
* Clinically significant abnormal findings
* History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
* Has smoked or used tobacco products within 60 days prior to the first dose of study medication
* Has donated blood or plasma within 30 days prior to the first dose of study medication
* Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
18 Years
ALL
Yes
Sponsors
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Charleston Laboratories, Inc
INDUSTRY
Responsible Party
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Joseph Hazelton
Vice-President, Regulatory Affairs
Other Identifiers
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CLCT-004
Identifier Type: -
Identifier Source: org_study_id
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