COV155

DRUG4 trials

Sponsors

Mallinckrodt

Conditions

BunionChronic Low Back PainOsteoarthritis, HipOsteoarthritis, KneePain, PostoperativePharmacokinetics

Phase 1

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

CompletedNCT02561650

MallinckrodtPharmacokinetics

Start: 2011-12-31End: 2011-12-31Updated: 2016-10-19

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

CompletedNCT02561741

MallinckrodtPharmacokinetics

Start: 2012-12-31End: 2012-12-31Updated: 2016-10-19

Phase 3

Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)

CompletedNCT01722864

MallinckrodtChronic Low Back Pain, Osteoarthritis, Hip, Osteoarthritis, Knee

Start: 2012-11-30End: 2013-08-31Updated: 2016-10-19

Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain

CompletedNCT01743625

MallinckrodtBunion, Pain, Postoperative

Start: 2012-11-30End: 2013-07-31Updated: 2016-10-19

Related Papers

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.

2015-11-272 citations

Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.

2015-04-236 citations