A Phase 1 interventional study of Warfarin and warfarin plus ABT-335 plus rosuvastatin 5 mg in Healthy, sponsored by AstraZeneca. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-28.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
Drug: Warfarin
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
Also known as: Coumadin
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
Also known as: warfarin, coumadin ABT-335, fenofibric acid, Trilipix Rosuvastatin, Crestor
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
Also known as: warfarin, coumadin, ABT-335, fenofibric acid, Trilipix Rosuvastatin, Crestor
Pharmacokinetic parameters, pharmacodynamic variables
Time frame: Day 24
Vital signs, physical examinations, laboratory tests, ECGs, adverse events
Time frame: Day 29
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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