NCT01168336

Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects

Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Escalating Doses of Extended Release and Standard Formulations of Betahistine as Monotherapy and as Adjunctive to Olanzapine in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: OBEcure Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered with olanzapine and to determine potential dose limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of either medication, with particular emphasis on somnolence and weight gain secondary to olanzapine treatment

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Betahistine standard formulation	betahistine 24 mg tablets
DRUG	Betahistine Extended Release formulation	betahistine 32 mg tablets
DRUG	Placebo	matching placebo

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-07-23
• Last updated: 2010-12-30

Locations

2 sites across 1 country: Romania