Phase 1 Completed N=20 Randomized Basic Science

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

Healthy

Source: ClinicalTrials.gov NCT02465866 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data — 20.0; 17.9; 18.4; 17.5 ng/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data	20.0; 17.9; 18.4; 17.5; 4.71; 3.27	—
PRIMARY Time to Reach Maximum Concentration (Tmax)	1.55; 3.38; 1.39; 3.09; 0.91; 2.84	—
PRIMARY Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data	0.556; 0.523; 0.465; 0.527; 0.0741; 0.0917	—
PRIMARY Time of the Last Quantifiable Concentration (Tlast)	27.80; 31.21; 28.81; 31.58; 23.38; 24.01	—
PRIMARY Observed Elimination Rate Constant (λz)	0.1468; 0.1373; 0.1415; 0.1371; 0.1577; 0.1359	—
PRIMARY Observed Terminal Elimination Half-life (T1/2)	4.93; 5.22; 5.13; 5.26; 4.59; 5.22	—
PRIMARY Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine	0.08870; 0.03786; 0.1219; 0.02250; 0.01086; 0.003941	—
PRIMARY AUC0-0.50 for Hydrocodone and Promethazine	0.9532; 0.2566; 1.280; 0.3163; 0.03535; 0.01570	—
PRIMARY AUC0-0.75 for Hydrocodone and Promethazine	3.194; 0.8759; 4.027; 1.276; 0.1108; 0.05549	—
PRIMARY AUC0-1.0 for Hydrocodone and Promethazine	6.383; 2.046; 7.524; 2.722; 0.2578; 0.1457	—
PRIMARY AUC0-1.5 for Hydrocodone and Promethazine	14.33; 5.782; 14.95; 6.424; 0.8524; 0.5573	—
PRIMARY AUC0-2.0 for Hydrocodone and Promethazine	23.21; 10.95; 22.53; 11.04; 1.938; 1.267	—
PRIMARY AUC0-4.0 for Hydrocodone and Promethazine	54.04; 38.97; 48.35; 35.14; 9.124; 5.943	—
PRIMARY Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration	146.2; 151.9; 130.9; 148.5; 19.19; 17.85	—
PRIMARY Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity	150.2; 155.8; 134.3; 152.4; 96.92; 60.72	—
PRIMARY Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation	2.72; 2.68; 2.65; 2.71; 14.35; 13.54	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02465866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.