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A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules

NCT03801148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-03-19

Study results available
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Summary

The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).

Conditions

  • Healthy Volunteers

Interventions

DRUG

30 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release capsules.

DRUG

30 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release capsules.

DRUG

60 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release capsules.

DRUG

60 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release capsules.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2019-02-25
Completion
2019-04-09
FDA Drug
Yes

Countries

  • United States

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 NCT03801148 on ClinicalTrials.gov