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.

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. - Taspoglutide BE study in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34034

Enrollment

100

Registered

2010-10-22

Start date

2010-10-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

diabetes diabetes mellitus type 2

Interventions

Taspoglutide injection

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female (Non child bearing potential) 18-65 years of age, inclusive BMI >20 AND

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Pharmacodynamics Safety Tolerability	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)