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Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

NCT00839683•AstraZeneca

View on ClinicalTrials.gov

Summary

Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2

Exclusion Criteria

•Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
•Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
•Glucosuria at screening
•Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
•Presence of edema on physical exam
•History of diabetes mellitus
•History of heart failure
•History of renal insufficiency
•History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
•History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections
+10 more criteria

Locations (1)

Mds Pharma Services (Us) Inc.

Neptune City, New Jersey, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

October 17, 2016

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

simvastatin

DRUG

Dapagliflozin

DRUG

simvastatin

DRUG

valsartan

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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