The PK and safety profiles to be examined following a single oral administration of
TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to
subjects with normal renal function.
Drug: beraprost sodium(BPS)
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Full eligibility criteria for NCT01443429
Ages eligible for Study
20 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
The eGFR 1 day before study drug administration are stipulated as follows.
Subjects with normal renal function : ≥90
Patients with mild renal impairment : ≥60 to <90
Patients with moderate renal impairment : ≥30 to <60
Patients with severe renal impairment : ≥15 to <30
Patients on dialysis
Patients who have a history of undergoing renal transplantation
Patients with diabetes mellitus
All locations for NCT01443429
View full eligibility
Tris trial is registered with FDA with number: NCT01443429. The sponsor of the trial is Toray Industries, Inc and it is looking for 24 volunteers for the current phase.
Official trial title: A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese Patients With Renal Impairment as Compared to Subjects With Normal Renal Function
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