Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CL-108 Drug: Vicoprofen Drug: Ultracet Drug: Phenergan Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
Experimental: Treatment A: CL-108 (Fasted)
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Drug: CL-108
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth

Experimental: Treatment B: CL-108 (Fed)
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Drug: CL-108
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth

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
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

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
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




Primary Outcome Measures :
  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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Layout table for additonal information
Responsible Party: Joseph Hazelton, Vice-President, Regulatory Affairs, Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT02465866     History of Changes
Other Study ID Numbers: CLCT-004
First Posted: June 9, 2015    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: May 2, 2017
Last Verified: March 2017
Keywords provided by Joseph Hazelton, Charleston Laboratories, Inc:
Plasma concentration
Time to plasma concentration
Elimination rate constant
Elimination half life
Area under the curve
Additional relevant MeSH terms:
Layout table for MeSH terms
Promethazine
Diphenhydramine
Sleep Aids, Pharmaceutical
Malnutrition
Nutrition Disorders
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents