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JZP-258 versus Xyrem pharmacokinetic and bioequivalence crossover study in healthy adults
NL-OMON41817Active, not recruiting
- Sponsor
- Jazz Pharmaceuticals plc
- Start
- Aug 2014
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Randomised, open-label trial of sodium oxybate + calcium oxybate + potassium oxybate + magnesium oxybate and sodium oxybate in narcolepsy (8 arms), sponsored by Jazz Pharmaceuticals plc. Primary endpoints: Relative bioavailability and bioequivalence of JZP-258 versus Xyrem under fasting and fed conditions, Food effect on JZP-258 pharmacokinetics and 2 more. Started Aug 2014; status: active, not recruiting.
02
Drugs
sodium oxybate + calcium oxybate + potassium oxybate + magnesium oxybatesodium oxybate
03
Conditions
narcolepsy
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