A placebo-controlled pharmacodynamic and pharmacokinetic interaction study between tamsulosin and acenocoumarol.
OBJECTIVE
To evaluate pharmacokinetic and pharmacodynamic interactions between tamsulosin and acenocoumarol.


METHODS
Twelve healthy volunteers received tamsulosin 0.4 mg or placebo once daily for 9 days in a double-blind, cross-over study. On day 5 of each study period, a single 10-mg oral dose of racemic acenocoumarol was administered.


RESULTS
The ratios (point estimates (90% confidence intervals)) of values in the presence and absence of tamsulosin were: AUCPT 1.01 (0.98, 1.03); maximum prothrombin time (Ptmax) 0.99 (0.94, 1.05); AUC (R)-acenocoumarol 1.02 (0.90, 1.16), and AUC (S)-acenocoumarol 1.03 (0.89, 1.20). Both combinations, tamsulosin and placebo with acenocoumarol, were well-tolerated.


CONCLUSIONS
Multiple doses of tamsulosin had no effect on the pharmacokinetics or pharmacodynamics of a single high dose of acenocoumarol.
Rolan
P
P
Medeval, Skelton House, Manchester, UK. p.rolan@medeval.com
Terpstra
I J
IJ
Clarke
C
C
Mullins
F
F
Visser
J N
JN
D000074:Acenocoumarol / Q000493:pharmacokinetics* / Q000494:pharmacology; D000284:Administration, Oral; D000293:Adolescent; D000317:Adrenergic alpha-Antagonists / Q000494:pharmacology*; D000328:Adult; D000925:Anticoagulants / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D006801:Humans; D008297:Male; D011517:Prothrombin Time; D013449:Sulfonamides / Q000494:pharmacology*; D000077409:Tamsulosin
D000317:Adrenergic alpha-Antagonists; D000925:Anticoagulants; D013449:Sulfonamides; D000077409:Tamsulosin; D000074:Acenocoumarol