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.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
Timeframe: 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)
Timeframe: 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
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 0 (pre-dose) to 0.25 hours post-dose
AUC0-0.50 for Hydrocodone and Promethazine
Timeframe: 0 (pre-dose) to 0.5 hours post-dose
AUC0-0.75 for Hydrocodone and Promethazine
Timeframe: 0 (Pre-dose) to 0.75 hours post-dose
AUC0-1.0 for Hydrocodone and Promethazine
Timeframe: 0 (pre-dose) to 1.0 hours post-dose
AUC0-1.5 for Hydrocodone and Promethazine
Timeframe: 0 (pre-dose) to 1.5 hours post-dose
AUC0-2.0 for Hydrocodone and Promethazine
Timeframe: 0 (pre-dose) to 2 hours post-dose
AUC0-4.0 for Hydrocodone and Promethazine
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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