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A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)

NCT02529787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-08-20

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)

Conditions

  • Healthy

Interventions

DRUG

Doxirazole

1 capsule contains 60 mg Dexlansoprazole

DRUG

Dexilant

1 capsule contains 60 mg Dexlansoprazole

Sponsors & Collaborators

  • Hikma Pharma,Egypt

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • Egypt

Study Locations

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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 NCT02529787 on ClinicalTrials.gov