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To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: AZD1656 (Drug); Gemfibrozil (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Stanko Skrtic, Study Director, Affiliation: AstraZeneca
Aslak Rautio, Principal Investigator, Affiliation: Quintiles Hermelinen AB
Wolfgang Kuhn, Principal Investigator, Affiliation: Quintiles AB
Folke Sjöberg, Principal Investigator, Affiliation: J.J. Berzelius Clinical Research Center AB
Mirjana Kujacic, Study Chair, Affiliation: AstraZeneca

Summary

The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Clinical Details

Official title: A Randomised, Open, Placebo Controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.

Secondary outcome:

PK of AZD1656 when administered with placebo or following repeated dosing of germfibrozil by assessment of AUC0-t, tmax, t1/2, CL/F and Vz/F

PK of AZD1656 metabolite, when AZD1656 is administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC, AUC0-t, Cmax, tmax, t1/2

Safety of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables including 24-h plasma glucose, physical examination and adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with

metformin.

- Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

- Intake of another investigational drug within the last 30 days prior to enrolment.

- Clinically significant illness or clinically relevant trauma.

Locations and Contacts

Reserach Site, Linkoping, Sweden

Research Site, Lulea, Sweden

Research Site, Uppsala, Sweden

Additional Information

Starting date: March 2010
Last updated: June 30, 2010

Page last updated: August 23, 2015

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