Drug-Drug Interaction Study of TRK-100STP

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AST-120 (Kremezin®); Drug: TRK-100STP (BERASUS LA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719758

533-CL-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Description:

Cross-over study

Treatment:

Drug: TRK-100STP (BERASUS LA)

Drug: AST-120 (Kremezin®)