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Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

NCT01159145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-09-21

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH\>4 during 24 hours after dose on day 5.

Conditions

  • Pharmacodynamics Study

Interventions

DRUG

D961H

Oral, capsule

DRUG

Omeprazole

Oral, tablet

Sponsors & Collaborators

Principal Investigators

  • Masataka Date, MD PhD · AstraZeneca KK

  • Ippei Ikushima, MD, PhD · AstraZeneca KK

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Japan

Study Locations

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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 NCT01159145 on ClinicalTrials.gov