lichaamsgewicht body weight thyroid function
Conditions
Interventions
Active substance :olanzapine topiramate
Activity : anti-psychotic anti-epileptic
Indication : schizophrenia migraine and epilepsy
Strength : 10 mg 25 mg
Dosage form: tablet encapsulated tablet
Sponsors
Project Management
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male subjects 24-45 yrs, inclusive 22-30 kg/m2, inclusive
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 60 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effects of 14 days of daily dosing of 10 mg olanzapine with or without topiramate at a dose of 25 and 50 mg twice daily on body weight in healthy male subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess if olanzapine at a dose of 10 mg daily for 14 days with or without topiramate at a dose of 25 and 50 mg twice daily has an effect on thyroid function, glucose and lipid metabolism in healthy male subjects | — |
Countries
Netherlands
Outcome results
None listed