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Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects | Clinical Trials | Clareo Health

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Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

A Study to Characterize the Steady-State Pharmacokinetics and Pharmacodynamics of 2.5 mg Saxagliptin Administered Twice Daily With Meals to Healthy Subjects

NCT00935467•AstraZeneca

View on ClinicalTrials.gov

Summary

To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Men and women ages 18 to 45 inclusive
•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

•WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
•Any significant acute or chronic medical illness
•Current or recent (within 3 months) gastrointestinal disease
•Any major surgery within 4 weeks of study drug administration
•History of allergy to DPP4 inhibitor or related compounds
•Prior exposure to saxagliptin

Locations (1)

Ppd Development, Lp

Austin, Texas, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

August 1, 2009

Completion Date

August 1, 2009

Last Updated

May 5, 2015

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Saxagliptin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

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: May 5, 2015Data 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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Pharmacokinetics and Pharmacodynamics Study of Saxagliptin 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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