Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions

Phase 1 Completed 30 enrolled Mallinckrodt

NaSingle-groupOpen-label

Summary

A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.

Timeline

Start: 2012-12
Primary completion: 2012-12
Completion: 2012-12

Publications

Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single-dose pharmacokinetics of 2 or 3 tablets of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) under fed and fasted conditions: two randomized open-label trials. BMC Pharmacol Toxicol. 2015 Nov 27;16:31. doi: 10.1186/s40360-015-0032-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	975 mg	—
Subject	Hydrocodone	Unknown	22.5 mg	—

Indications

No indication recorded.