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A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CL-108
Vicoprofen
Ultracet
Phenergan
Sponsored by
Charleston Laboratories, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Plasma concentration, Time to plasma concentration, Elimination rate constant, Elimination half life, Area under the curve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent
  • 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 medical history
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Treatment A: CL-108 (Fasted)

    Treatment B: CL-108 (Fed)

    Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)

    Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)

    Arm Description

    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

    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 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

    Outcomes

    Primary Outcome Measures

    Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
    Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.
    Time to Reach Maximum Concentration (Tmax)
    Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
    Time of the Last Quantifiable Concentration (Tlast)
    Observed Elimination Rate Constant (λz)
    Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
    Observed Terminal Elimination Half-life (T1/2)
    Calculated as: T1/2 = ln(2)/λz
    Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
    AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-0.50 for Hydrocodone and Promethazine
    AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-0.75 for Hydrocodone and Promethazine
    AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-1.0 for Hydrocodone and Promethazine
    AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-1.5 for Hydrocodone and Promethazine
    AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-2.0 for Hydrocodone and Promethazine
    AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
    AUC0-4.0 for Hydrocodone and Promethazine
    AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
    Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
    Calculated using the linear trapezoidal rule
    Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
    Calculated as: AUCinf = AUClast + Clast/λz
    Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
    Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2015
    Last Updated
    March 30, 2017
    Sponsor
    Charleston Laboratories, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02465866
    Brief Title
    A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
    Official Title
    A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charleston Laboratories, Inc

    4. Oversight

    5. Study Description

    Brief Summary
    This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    Plasma concentration, Time to plasma concentration, Elimination rate constant, Elimination half life, Area under the curve

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A: CL-108 (Fasted)
    Arm Type
    Experimental
    Arm Description
    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
    Arm Title
    Treatment B: CL-108 (Fed)
    Arm Type
    Experimental
    Arm Description
    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
    Arm Title
    Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)
    Arm Type
    Active Comparator
    Arm Description
    Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
    Arm Title
    Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
    Arm Type
    Active Comparator
    Arm Description
    Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
    Intervention Type
    Drug
    Intervention Name(s)
    CL-108
    Intervention Description
    Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
    Intervention Type
    Drug
    Intervention Name(s)
    Vicoprofen
    Intervention Description
    Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
    Intervention Type
    Drug
    Intervention Name(s)
    Ultracet
    Intervention Description
    Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
    Intervention Type
    Drug
    Intervention Name(s)
    Phenergan
    Other Intervention Name(s)
    Promethazine HCl
    Intervention Description
    Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
    Primary Outcome Measure Information:
    Title
    Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
    Description
    Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Time to Reach Maximum Concentration (Tmax)
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Time of the Last Quantifiable Concentration (Tlast)
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Observed Elimination Rate Constant (λz)
    Description
    Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Observed Terminal Elimination Half-life (T1/2)
    Description
    Calculated as: T1/2 = ln(2)/λz
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
    Description
    AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 0.25 hours post-dose
    Title
    AUC0-0.50 for Hydrocodone and Promethazine
    Description
    AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 0.5 hours post-dose
    Title
    AUC0-0.75 for Hydrocodone and Promethazine
    Description
    AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (Pre-dose) to 0.75 hours post-dose
    Title
    AUC0-1.0 for Hydrocodone and Promethazine
    Description
    AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 1.0 hours post-dose
    Title
    AUC0-1.5 for Hydrocodone and Promethazine
    Description
    AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 1.5 hours post-dose
    Title
    AUC0-2.0 for Hydrocodone and Promethazine
    Description
    AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 2 hours post-dose
    Title
    AUC0-4.0 for Hydrocodone and Promethazine
    Description
    AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
    Time Frame
    0 (pre-dose) to 4 hours post-dose
    Title
    Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
    Description
    Calculated using the linear trapezoidal rule
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
    Description
    Calculated as: AUCinf = AUClast + Clast/λz
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
    Title
    Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
    Description
    Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100
    Time Frame
    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent 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 medical history 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.

    12. IPD Sharing Statement

    Learn more about this trial

    A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

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