Bioequivalence of Levomethadone versus Physeptone mix/Methadone mix
Research type
Research Study
Full title
A randomised, open-label, 2 parallel cohorts, single dose, crossover study in healthy volunteers to evaluate the influence of excipients on the bioequivalence of the two oral preparations Levomethadone Molteni 0.5 mg/ml oral solution versus Physeptone mixture/Methadone Mixture DTF 1mg/ml.
IRAS ID
248442
Contact name
Ulrike Lorch
Contact email
Eudract number
2017-005176-26
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
The purpose of this study is to assess if Levomethadone Molteni 0.5 mg/ml(Levometadone Molteni) is similar to Physeptone mixture/Methadone Mixture DTF 1 mg/ml (Physeptone) (i.e. bioequivalent), when given with the highest dose of respective excipients, to healthy volunteers in a fasting state. For this purpose, in addition to Levomethadone Molteni and Physeptone, two additional solutions containing only the respective excipients will also be administered.
In order to counteract the effects of methadone and levomethadone, naltrexone will also be administered pre-and post-dose. Naltrexone is a drug that blocks the response of other opioids by binding to a receptor (opioid receptor antagonist). It does not seem to affect the pharmacokinetics of methadone or levomethadone.
This will be a randomised, 2-cohort, single dose, crossover study in a total of 60 healthy volunteers. The doses they receive will be the lowest doses of methadone (10mg) and levomethadone (5mg). All volunteers will be randomly allocated to one of two cohorts and take part in two treatment periods separated by a washout period. In Treatment Period 1 they will receive Levomethadone Molteni or Physeptone with or without their respective excipients solutions co-administered with naltrexone and vice versa in Treatment Period 2.
Subjects will be screened prior to entering the study and will remain on the unit for a total of 5 days. The wash-out interval will be a minimum of 14 days followed by Treatment Period 2 with an in-unit stay of 5 days after which they will be followed-up 7-10 days post-discharge.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0298
Date of REC Opinion
23 Jul 2018
REC opinion
Favourable Opinion