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

Charleston Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Vicoprofen; Drug: Ultracet; Drug: Phenergan; Drug: CL-108

Study type: Interventional

Funder types: Industry

Identifiers

NCT02465866

CLCT-004

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Treatment A: CL-108 (Fasted)

Experimental group

Description:

CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

Treatment:

Drug: CL-108

Treatment B: CL-108 (Fed)

Experimental group

Description:

CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

Treatment:

Drug: CL-108

Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)

Active Comparator group

Description:

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:

Drug: Ultracet

Drug: Vicoprofen

Drug: Phenergan

Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)

Active Comparator group

Description:

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:

Drug: Ultracet

Drug: Vicoprofen

Drug: Phenergan