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Completed

NCT Number: NCT02465866

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CL-108

Drug

Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth

Vicoprofen

Drug

Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth

Ultracet

Drug

Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth

Phenergan

Drug

Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth

Other names: Promethazine HCl

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

Charleston Laboratories, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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