A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)

Dapagliflozin

Intervention Type DRUG

Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days

2

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)

Dapagliflozin

Intervention Type DRUG

Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days

Interventions

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Dapagliflozin

Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)

Intervention Type DRUG

Dapagliflozin

Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination
* Have normal physical exam, vital signs ECG findings, and laboratory values

Exclusion Criteria

* Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
* History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator
* Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes