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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Phase 1, Multi-center, Open-label, 3-arm, Fixed Sequence Study to Assess the Effect of Co-administration of AZD9833 on the Pharmacokinetics of Midazolam (CYP3A4/5 Substrate), of Omeprazole (CYP2C19 Substrate), of Celecoxib (CYP2C9 Substrate) and of Dabigatran Etexilate (P-gp Transporter Substrate) in Healthy Postmenopausal Female Volunteers

Study ID: NCT05438303

Study Description

Brief Summary: This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites

Detailed Description: Participants will be randomized to one of 3 treatment arms on Day 1 prior to Investigational Medicinal Product (IMP) administration: * Arm A: single oral doses of midazolam and omeprazole administered together + repeated doses of AZD9833 . * Arm B: single oral doses of dabigatran etexilate + single oral dose of AZD9833 . * Arm C: single oral doses of celecoxib + repeated oral doses of AZD9833. Each participant will be involved in the study for up to 7 to 8 weeks

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Research Site, Long Beach, California, United States

Research Site, Berlin, New Jersey, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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