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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: CL-108 (Fasted) | Experimental | CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition |
|
| Treatment B: CL-108 (Fed) | Experimental | CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition |
|
| Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) | Active Comparator | Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition |
|
| Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) | Active Comparator | Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL-108 | Drug | Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 to Reach Maximum Concentration (Tmax) | 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 | 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) | 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) | Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile | 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 Terminal Elimination Half-life (T1/2) | Calculated as: T1/2 = ln(2)/λz | 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 |
| Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty healthy subjects were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: ABDC | Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Dosing in 4 study periods was separated by a 14-day washout period |
| FG001 | Sequence 2: BCAD | Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition Dosing in 4 study periods was separated by a 14-day washout period |
| FG002 | Sequence 3: CDBA | Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Dosing in 4 study periods was separated by a 14-day washout period |
| FG003 | Sequence 4: DACB | Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Dosing in 4 study periods was separated by a 14-day washout period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 1: Washout (14 Days) |
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| Period 2 |
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| Period 2: Washout (14 Days) |
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| Period 3 |
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| Period 3: Washout (14 Days) |
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| Period 4 |
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| Period 4: Washout (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intended to treat (ITT) population | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
Up to day 72
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: CL-108 (Fasted) | CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Commercial Officer | Charleston Laboratories, Inc | 561-748-2007 | cliregulatory@charlestonlabs.com |
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| ID | Term |
|---|---|
| C409362 | hydrocodone tartrate, ibuprofen drug combination |
| C478659 | Ultracet |
| D011398 | Promethazine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
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| 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 |
|
|
AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
| 0 (pre-dose) to 0.25 hours post-dose |
| AUC0-0.50 for Hydrocodone and Promethazine | AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (pre-dose) to 0.5 hours post-dose |
| AUC0-0.75 for Hydrocodone and Promethazine | AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (Pre-dose) to 0.75 hours post-dose |
| AUC0-1.0 for Hydrocodone and Promethazine | AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (pre-dose) to 1.0 hours post-dose |
| AUC0-1.5 for Hydrocodone and Promethazine | AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (pre-dose) to 1.5 hours post-dose |
| AUC0-2.0 for Hydrocodone and Promethazine | AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (pre-dose) to 2 hours post-dose |
| AUC0-4.0 for Hydrocodone and Promethazine | AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method. | 0 (pre-dose) to 4 hours post-dose |
| 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 | 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 |
| Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity | Calculated as: AUCinf = AUClast + Clast/λz | 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 |
| Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation | Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
| OG002 | 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 |
| OG003 | 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 |
|
|
| Primary | Time to Reach Maximum Concentration (Tmax) | ITT population | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| Primary | Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data | ITT population | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| Primary | Time of the Last Quantifiable Concentration (Tlast) | ITT population | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
| Primary | 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 | ITT population | Posted | Mean | Standard Deviation | h-1 | 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 |
|
|
|
| Primary | Observed Terminal Elimination Half-life (T1/2) | Calculated as: T1/2 = ln(2)/λz | ITT population | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| Primary | 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. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 0.25 hours post-dose |
|
|
|
| Primary | AUC0-0.50 for Hydrocodone and Promethazine | AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 0.5 hours post-dose |
|
|
|
| Primary | AUC0-0.75 for Hydrocodone and Promethazine | AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (Pre-dose) to 0.75 hours post-dose |
|
|
|
| Primary | AUC0-1.0 for Hydrocodone and Promethazine | AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 1.0 hours post-dose |
|
|
|
| Primary | AUC0-1.5 for Hydrocodone and Promethazine | AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 1.5 hours post-dose |
|
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| Primary | AUC0-2.0 for Hydrocodone and Promethazine | AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 2 hours post-dose |
|
|
|
| Primary | AUC0-4.0 for Hydrocodone and Promethazine | AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method. | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 0 (pre-dose) to 4 hours post-dose |
|
|
|
| Primary | 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 | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
|
|
|
| Primary | Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity | Calculated as: AUCinf = AUClast + Clast/λz | ITT population | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
|
|
|
| Primary | Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation | Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100 | ITT population | Posted | Mean | Standard Deviation | Percentage of AUCExtrap | 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 |
|
|
|
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | Treatment B: CL-108 (Fed) | CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition | 0 | 20 | 11 | 20 |
| EG002 | 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 | 0 | 20 | 20 | 20 |
| EG003 | 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 | 0 | 19 | 2 | 19 |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D013457 |
| Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Acetaminophen |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Acetaminophen |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Acetaminophen |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Acetaminophen |
|
| Promethazine (Number of Participants=19,18,20,18) |
|
| Acetaminophen |
|
| Promethazine (Number of Participants=19,18,20,18) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Acetaminophen |
|
| Promethazine (Number of Participants=19,19,20,19) |
|
| Promethazine (Number of Participants=19,18,20,18) |
|
| Promethazine (Number of Participants=19,18,20,18) |
|