Overview
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
Status:
Completed
Completed
Trial end date:
2014-02-01
2014-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Toray Industries, IncTreatments:
Beraprost
Epoprostenol
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- Patients on dialysis
- Patients who have a history of undergoing renal transplantation
- Patients with diabetes mellitus