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A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet

NCT03456960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2019-11-19

Study results available
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Summary

The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-438ASA

TAK-438ASA tablet.

DRUG

TAK-438

TAK-438 tablet.

DRUG

Aspirin

Aspirin enteric-coated tablet.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2018-10-10
Completion
2018-10-12

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT03456960 on ClinicalTrials.gov