経口prostacyclin誘導体beraprost sodium (TRK-100) の第I相臨床試験
10日間連続投与試験
1989 年 20 巻 3 号 p. 529-539
詳細
1989 年 20 巻 3 号 p. 529-539
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.
