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CompletedNCT00676117Updated Mar 12, 2009

Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males

A Phase 1 interventional study of Esomeprazole (D961H) and Loxoprofen in Healthy, sponsored by AstraZeneca. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).

02

Conditions studied

  • Healthy

Keywords

  • male
  • Japan
  • Japanese
  • Healthy volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Japanese male
  • Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
  • Body weight 50-80 kg

Exclusion criteria

Exclusion Criteria:

  • Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders
  • Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s) , eg, acute inflammatory disease which requires medical intervention
  • Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    Drug: Esomeprazole (D961H)

  • Active comparator
    2

    Drug: Loxoprofen

Interventions

  • DrugEsomeprazole (D961H)

    20mg

    Also known as: Nexium

  • DrugLoxoprofen

    60mg tablet

    Also known as: Loxonin

06

What researchers measure

Primary outcomes

  1. pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.

    Time frame: 5-7 days after the last dose of study medication is given

Secondary outcomes

  1. The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature

    Time frame: 5-7 days after the last dose of study medication is given

07

Study locations

1 site
  • Research Site
    Osaka-city, Osaka, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00676117
Lead sponsor
AstraZeneca
First posted
May 12, 2008
Start date
Apr 2008
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Mar 12, 2009

Study contacts

Naotsugu Oyama, MD, PhD
study director · AstraZeneca
Michio Yagi
principal investigator · Osaka Pharmacology Clinical Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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