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Nonsteroidal Anti-inflammatory Drug

AZD9833 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until post study (5 to 7 days post final dose) (assessed up to 6 months)
Awards & highlights

Study Summary

This trial will study how different drugs interact with each other in healthy postmenopausal women.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until post study (5 to 7 days post final dose) (assessed up to 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until post study (5 to 7 days post final dose) (assessed up to 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under plasma concentration time curve from zero to infinity (AUCinf) of midazolam, omeprazole, total dabigatran, and celecoxib
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of midazolam, omeprazole, total dabigatran, and celecoxib
Maximum observed plasma concentration (Cmax) of midazolam, omeprazole, dabigatran etexilate and celecoxib
Secondary outcome measures
AUCinf for AZD9833 and free dabigatran
AUClast for AZD9833 and free dabigatran
Apparent total body clearance from plasma after extravascular administration (CL/F) for AZD9833 and free dabigatran
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (Celecoxib)Experimental Treatment2 Interventions
Participants will receive single oral doses of celecoxib (Day 1 of Treatment Periods 1 and 3) and repeated oral doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3)
Group II: Arm B (Dabigatran etexilate)Experimental Treatment2 Interventions
Participants will receive single oral doses of dabigatran etexilate (Day 1 of Treatment Periods 1 and 2) and single oral dose of AZD9833 (Day 1 of Treatment Period 2)
Group III: Arm A (midazolam and omeprazole)Experimental Treatment3 Interventions
Participants will receive single oral doses of midazolam and omeprazole together (Day 1 of Treatment Periods 1 and 3) and repeated doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9833
2021
Completed Phase 2
~230
Midazolam
FDA approved
Omeprazole
FDA approved
Dabigatran etexilate
FDA approved
Celecoxib
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,611,922 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
2022. "Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438303.
~21 spots leftby Apr 2025
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