Conditions: Healthy
Keywords: Plasma concentration Time to plasma concentration Elimination rate constant Elimination half life Area under the curve
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

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:

Arms:
arm 1: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition arm 2: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition arm 3: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition arm 4: 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: intervention 1: CL-108 intervention 2: Vicoprofen intervention 3: Ultracet intervention 4: Phenergan
Intervention descriptions: intervention 1: Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth intervention 2: Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth intervention 3: Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth intervention 4: Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth

Protocol document: