Healthy
Conditions
Keywords
TRK-100STP,, beraprost sodium,, Careload LA, AST-120, Spherical carbon adsorbent, Drug-drug interaction
Brief summary
The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120
Detailed description
Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.
Interventions
DRUGTRK-100STP (BERASUS LA)
oral
oral
Sponsors
Toray Industries, Inc
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent * Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg
Exclusion criteria
* Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments * Receives any investigational medicine within 120 days before screening * Recent blood donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters (vital signs, ECG, laboratory tests) | 1 day |
Countries
Japan
Outcome results
None listed