Phase i study of beraprost sodium (TRK-100), a prostacyclin derivative - Repeated oral administration study for 10 days.:Repeated Oral Administration Study for 10 Days

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A phase I study by repeated oral administration of beraprost sodium (TRK-100), a pros-tacyclin derivative, was performed in 12 healthy male volunteers. The safety, pharmaco-kinetics, and pharmacological effects were studied in repeated oral administration for 10days. The volunteers were randomly divided into two groups. Six men received 75μg/day t.j.d.for 10 days and the remaining six men were given 150μg/day t.i.d. for 10 days. 1) Subjective symptoms: Facial flushing, feeling of congestion, dull headache, and headache, etc., appeared in some subjects. These symptoms were observed more frequently in the group receiving 150μg/day. 2) Physical and laboratory tests: No abnormality was observed. 3) Pharmacokinetics: No accumulation of TRK-100 was observed in the group receiving 150μg/day. 4) Pharmacological effect: TRK-100 inhibited platelet aggregation induced by ADP, collagen, and epinephrine, and platelet adhesion. The above results indicated the safety and the pharmacological effects of TRK-100 in repeated oral administration in healthy male volunteers.
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