MedTrace Logo

TAK-438 Bismuth Drug Interaction Study

NCT02892409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-03

Study results available
· View outcomes & findings →

Summary

To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.

Conditions

  • Helicobacter Pylori

Interventions

DRUG

Clarithromycin

Clarithromycin tablets

DRUG

Amoxicillin

Amoxicillin capsules

DRUG

Tripotassium bismuth dicitrate

Tripotassium bismuth dicitrate tablets

DRUG

Lansoprazole

Lansoprazole capsules

DRUG

TAK-438

TAK-438 tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2017-04-17
Completion
2017-05-11

Countries

  • South Korea

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 NCT02892409 on ClinicalTrials.gov