To Evaluate the Bioavailability of a Tablet of AZD1656

A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817505

Enrollment

Registered

2009-01-06

Start date

2008-12-31

Completion date

2009-09-30

Last updated

2009-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type I diabetes, bioavailability

Brief summary

To evaluate the bioavailability of a tablet of AZD1656.

Interventions

DRUGAZD1656

Single dose oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female, type I diabetes patients, female with non child-bearing potential. * Treated with insulin for more than 3 years. Well controlled HbA1c. * Have a body mass index (BMI) ≥19 and ≤35

Exclusion criteria

* Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product * Daily use of nicotine containing substances.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)	Blood samples taken up to 72 hours

Secondary

Measure	Time frame
Pharmacodynamic variables (Plasma glucose)	Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)	Taken during treatment periods

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026