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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| betahistine | Experimental | Betahistine 24 mg tablets |
|
| betahistine XR | Experimental | betahistine 32 mg tablets |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betahistine standard formulation | Drug | betahistine 24 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine | The total expected duration of the study for each subject will be 7 weeks. Total exposure time to Betahistine alone will be 1 week and total exposure time to Betahistine plus Olanzapine will be 3 weeks. | thisoutcome will be assssed 7 weeks after radomization. |
| Evaluation of drug-drug interactions and pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as adjunctive to olanzapine | 4 weeks | |
| Evaluation of pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodica Cinca, Prof MD | Pierrel Research HP-RO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierrel Research HP-RO | Arad | Romania | ||||
| Pierrel Research HP-RO |
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| ID | Term |
|---|---|
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Betahistine Extended Release formulation |
| Drug |
betahistine 32 mg tablets |
|
| Placebo | Drug | matching placebo |
|
| Timișoara |
| RO-300244 |
| Romania |