Replies to post #152182 on Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

LOL yes, those are routine SAFETY tests, where does to say OXY or NAL??????????

also I see those are SECONDARY outcome measures, whereas previously it was claimed that the FDA is not asking that the efficacy of OXY as a pain reliever to be tested, a claim that is clearly wrong.

[WeeZuhl]

The other Phase III specifically describes naltrexone pharmacokinetics.


https://clinicaltrials.gov/ct2/show/NCT02391571?term=Elite+Laboratories&rank=1

A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects

Secondary Outcome Measures:

Secondary: Pharmacokinetic Profile of Naltrexone and 6ß-Naltrexol in Subjects receiving Oxycodone/Naltrexone [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

To investigate the multiple dose pharmacokinetics of naltrexone, and 6ß-naltrexol following repeated daily administration of Oxycodone/Naltrexone in methadone-maintained opioid dependent subjects. All subjects enrolled will have 3 PK samples taken during the placebo period and 3-13 samples taken during days 6-10 of the study. Samples will also be taken during the wash-out period, 2 on Day 11, then daily through Day 14. T max, Cmax AUC Ctrough and apparent first-order terminal elimination half-life will be calculated as part of the PK profile.

It appears that in this Phase III study, when Elite intended for the naltrexone levels to be measured, they specifically said so on clinicaltrials.gov. You may take it for whatever it's worth.