A multi-center, single-dose, open-label, randomized, parallel group study to investigate the reduction of initial taspoglutide Cmax after administration of 20 mg taspoglutide 10% Sustained Release Formulation (SRF) using three modified formulations as compared to the current Phase 3 formulation in healthy volunteers.
- Conditions
- diabetesdiabetes mellitus type 210018424
- Registration Number
- NL-OMON34034
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Healthy male or female (Non child bearing potential)
18-65 years of age, inclusive
BMI >20 AND <<= 35 kg/m2
Non-smoker, or not more than 10 cigarettes/day for at least six months before drug administration
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of having participated in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months prior to the start of this study, or when having donated more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the start of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics<br /><br>Pharmacodynamics<br /><br>Safety<br /><br>Tolerability</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>