NCT03042299

A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation

A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Detailed description

The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Conditions

• Japanese Healthy Adult Male Participants

Interventions

Type	Name	Description
DRUG	TAK-536	TAK-536 granules.
DRUG	TAK-536	TAK-536 tablet.

Timeline

• Start date: 2017-02-10
• Primary completion: 2017-03-11
• Completion: 2017-03-11
• First posted: 2017-02-03
• Last updated: 2018-11-14
• Results posted: 2018-10-09

Locations

1 site across 1 country: Japan