To Evaluate the Bioavailability of a Tablet of AZD1656

NCT ID: NCT00817505

Last Updated: 2009-11-03

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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To evaluate the bioavailability of a tablet of AZD1656.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD1656 tablet + food

Group Type ACTIVE_COMPARATOR

AZD1656

Intervention Type DRUG

Single dose oral tablet

AZD1656

Intervention Type DRUG

Single dose oral suspension

2

AZD1656 susp. without food

Group Type ACTIVE_COMPARATOR

AZD1656

Intervention Type DRUG

Single dose oral tablet

AZD1656

Intervention Type DRUG

Single dose oral suspension

3

AZD1656 tablet

Group Type ACTIVE_COMPARATOR

AZD1656

Intervention Type DRUG

Single dose oral tablet

AZD1656

Intervention Type DRUG

Single dose oral suspension

Interventions

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AZD1656

Single dose oral tablet

Intervention Type DRUG

AZD1656

Single dose oral suspension

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Klas Malmberg, MD, PhD, Prof

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Emanuel P DeNoia, MD

Role: PRINCIPAL_INVESTIGATOR

Healthcare Discoveries LLC Icon Development Solutions

Locations

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Research site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D1020C00010

Identifier Type: -

Identifier Source: org_study_id

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