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A Bioequivalence Study of TAK-536 Pediatric Formulation

NCT02401464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-07-06

Study results available
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Summary

The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.

Conditions

  • Japanese Healthy Adult Males

Interventions

DRUG

TAK-536 Tablet

TAK-536 10 mg tablet

DRUG

TAK-536 Dry Syrup Formulation

TAK-536 dry syrup formulation

DRUG

TAK-536 Ganule Formulation

TAK-536 granule formulation

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401464 on ClinicalTrials.gov