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Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

NCT03131895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-06-14

Study results available
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Summary

The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).

Conditions

  • Healthy Volunteers

Interventions

DRUG

30 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release.

DRUG

30 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release.

DRUG

60 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release.

DRUG

60 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release.

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
2017-04-25
Primary Completion
2017-07-03
Completion
2017-07-31
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 NCT03131895 on ClinicalTrials.gov