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

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ClinicalTrials.gov Identifier: NCT02465866
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : March 20, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Hazelton, Charleston Laboratories, Inc

Tracking Information
First Submitted Date  ICMJE June 4, 2015
First Posted Date  ICMJE June 9, 2015
Results First Submitted Date  ICMJE November 14, 2016
Results First Posted Date  ICMJE March 20, 2017
Last Update Posted Date May 2, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Maximum Drug Concentration (Cmax) in Plasma 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 ]
    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) [ 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 ]
  • 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 ]
  • 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 ]
  • Observed Elimination Rate Constant (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 ]
    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) [ 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 ]
    Calculated as: T1/2 = ln(2)/λz
  • Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 0.25 hours post-dose ]
    AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-0.50 for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 0.5 hours post-dose ]
    AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-0.75 for Hydrocodone and Promethazine [ Time Frame: 0 (Pre-dose) to 0.75 hours post-dose ]
    AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-1.0 for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 1.0 hours post-dose ]
    AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-1.5 for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 1.5 hours post-dose ]
    AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-2.0 for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 2 hours post-dose ]
    AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
  • AUC0-4.0 for Hydrocodone and Promethazine [ Time Frame: 0 (pre-dose) to 4 hours post-dose ]
    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 [ 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 ]
    Calculated using the linear trapezoidal rule
  • Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity [ 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 ]
    Calculated as: AUCinf = AUClast + Clast/λz
  • Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation [ 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 ]
    Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Plasma pharmacokinetics to assess relative bioavailability of CL-108 to comparator in the fed and fasted state [ Time Frame: 48 hours post dose ]
  • Pharmacokinetic plasma concentration [ Time Frame: 48 hours post dose ]
  • Pharmacokinetic parameter, time to plasma concentration [ Time Frame: 48 hours post dose ]
  • Pharmacokinetic parameter, elimination rate constant [ Time Frame: 48 hours post dose ]
  • Pharmacokinetic parameter, elimination half life [ Time Frame: 48 hours post dose ]
  • Pharmacokinetic parameter, area under the curve [ Time Frame: 48 hours post dose ]
Change History Complete list of historical versions of study NCT02465866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Official Title  ICMJE A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CL-108
    Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
  • Drug: Vicoprofen
    Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
  • Drug: Ultracet
    Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
  • Drug: Phenergan
    Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
    Other Name: Promethazine HCl
Study Arms  ICMJE
  • Experimental: Treatment A: CL-108 (Fasted)
    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
    Intervention: Drug: CL-108
  • Experimental: Treatment B: CL-108 (Fed)
    CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
    Intervention: Drug: CL-108
  • Active Comparator: 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
    Interventions:
    • Drug: Vicoprofen
    • Drug: Ultracet
    • Drug: Phenergan
  • Active Comparator: 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
    Interventions:
    • Drug: Vicoprofen
    • Drug: Ultracet
    • Drug: Phenergan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
20
Original Actual Enrollment  ICMJE
 (submitted: June 4, 2015)
19
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02465866
Other Study ID Numbers  ICMJE CLCT-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Hazelton, Charleston Laboratories, Inc
Study Sponsor  ICMJE Charleston Laboratories, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Charleston Laboratories, Inc
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP