Will Be Recruiting
Sponsor ID
20220137
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
Study Details
The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.
Protocol Summary
Primary Outcome Measures
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero extrapolated to Infinity (AUCinf) of Apremilast.
Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Apremilast
Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period
Maximum Observed Plasma Concentration (Cmax) of Apremilast.
Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period
Secondary Outcome Measures
Number of participants who experience treatment-emergent adverse events .
Timeframe: Baseline through end of study (up to approximately 12 days)
Number of participants who experience Serious adverse events
Timeframe: From Screening (Day-28) through end of study (up to approximately 40 days)
Locations
No locations found.