A Phase 1 interventional study of PPI-668 capsule and PPI-668 tablet in Pharmacokinetic Assessments in Healthy Volunteers, sponsored by Presidio Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-09.
Sponsored by Presidio Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.
Exclusion Criteria:
On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered
Drug: PPI-668 capsule · Drug: PPI-668 tablet
On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered
Drug: PPI-668 capsule · Drug: PPI-668 tablet
PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
Time frame: Days 1 - 8
PPI-668 maximum observed plasma concentration (Cmax)
Time frame: Days 1 - 8
PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
Time frame: Days 1 - 8
number of participants with adverse events
Time frame: Days 1 - 8
number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels
Time frame: Days 1 - 8
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Presidio Pharmaceuticals, Inc.