Lets look again more closely Argument.
The description of the trial in the paper was as a single-center, four-way crossover, open-label, dose-ranging, multiple-treatment study. There were four treatment groups: zolpidem oral tablets (AMBIEN, 5 or 10 mg) and zolpidem LS (5 or 10 mg). The sample was young healthy volunteers (N = 20 males, 23 females).
This matches Study 003 provided in the original Novadel NDA - see picture.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_MedR_P1.pdf
There is one minor discrepancy – the number of subjects in study 003 is shown as 48. But in the paper it is reported as 43. Five subjects were excluded in the original analysis as reported in the NDA.
Dodgy Russian study? Read the data discrepancies and falsifications of study 003:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_ClinPharmR_P1.pdf
It’s the same study. It is fake news there is some new study (imo of-course!)
Ann: ZolpiMist Clinical Results Published, page-41
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