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Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Dapagliflozin/Metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Aslak Rautio, Principal Investigator, Affiliation: Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden
Wolfgang Kühn, Principal Investigator, Affiliation: Quintiles AB, Global Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
Mirjana Kujacic, Study Chair, Affiliation: AZ Global Clinical Development, Pepparedsleden 1, 431 83 Mölndal, 431 83 Mölndal

Summary

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.

Clinical Details

Official title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.

Secondary outcome: To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy

- BMI 18-30 kg/m2

Exclusion Criteria:

- History of clinically significant illness.

- History of alcohol or drug abuse

Locations and Contacts

Research Site, Lulea, Sweden
Additional Information

Starting date: June 2010
Last updated: May 31, 2012

Page last updated: August 23, 2015

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