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Loxoprofen

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 12, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Loxoprofen · 1 trial · 1 indication

Phase 1 1
NCT00676117Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese MalesHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males
Healthy
NCT0067611730
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Study Endpoints

Primary Endpoints

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.
5-7 days after the last dose of study medication is given

Secondary Endpoints

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
5-7 days after the last dose of study medication is given
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Esomeprazole (D961H)DRUG20mg
LoxoprofenDRUG60mg tablet
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male * Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) * Body weight 50-80 kg Exclusion Criteria: * Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders * Significant clinical illness from the 2 weeks preceding the p...

Countries:Japan
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Frequently asked questions about Loxoprofen

What is Loxoprofen used for?

Loxoprofen is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial in Japan to assess a potential drug-drug interaction with esomeprazole. The drug is not approved and remains in clinical development.

Who makes Loxoprofen?

Loxoprofen is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational small molecule drug.

What phase is Loxoprofen in?

Loxoprofen is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to evaluate its safety and potential interactions with other medications.

What clinical trials is Loxoprofen in?

Loxoprofen has one completed Phase 1 clinical trial registered as NCT00676117. This study was a drug-drug interaction study of esomeprazole capsule and loxoprofen tablet after repeated oral administration in Japanese males. The trial enrolled 30 healthy male participants aged 20 years and older.

Is Loxoprofen the same as any other drug?

Loxoprofen is a distinct investigational drug being developed by AstraZeneca. No alternative names for this drug have been identified in the available clinical trial information. It is being studied as a standalone small molecule in clinical research.