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

NCT01168336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-12-30

No results posted yet for this study

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

DRUG

Betahistine standard formulation

betahistine 24 mg tablets

DRUG

Betahistine Extended Release formulation

betahistine 32 mg tablets

DRUG

Placebo

matching placebo

Sponsors & Collaborators

  • OBEcure Ltd.

    lead INDUSTRY

Principal Investigators

  • Rodica Cinca, Prof MD · Pierrel Research HP-RO

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01168336 on ClinicalTrials.gov