To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension
- Registration Number
- NCT00790153
- Lead Sponsor
- AstraZeneca
- Brief Summary
To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Healthy male volunteers.
- Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
- Have a body mass index (BMI) ≥19 and ≤30
Exclusion Criteria
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
- Daily use of nicotine containing substances.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Insulin Insulin 1 AZD1656 AZD1656
- Primary Outcome Measures
Name Time Method Pharmacodynamic variables Blood samples taken repeatedly up to 6 hours during study days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables Blood samples taken repeatedly during 24 hours on study day sessions Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) Taken repeatedly during treatment periods
Trial Locations
- Locations (1)
Research Site
🇺🇸Chula Vista, California, United States