Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition

Study Overview
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Brief Summary
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The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.

Detailed Description
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An open label, balanced, randomized, two treatment, two-sequence, two-period, single-dose, crossover comparative bioequivalence study of Olanzapine 5 mg OD Tablets, of Dr. Reddy's Laboratories Limited and Zyprexa Zydis 5 mg Tablets of Cardinal Health in healthy, human subjects under fed conditions.

Official Title
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An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Bioequivalence Study of Olanzapine 5 mg OD Tablets With Zyprexa Zydis 5 mg Tablets in Healthy Subjects Under Fed Conditions

Conditions
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Fed

Intervention / Treatment
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* Drug: Olanzapine OD Tablets 5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy human subjects within the age range of 18 to 45 years Non-smokers since at least six months Willingness to provide written informed consent to participate in the study Body-mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2, with body weight not less than 50 kg Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening Normal 12-lead ECG or one with abnormality considered to be clinically insignificant Normal chest X-ray PA view Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol Female Subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams. Jellies, diaphragm, intrauterine device (IUD), or abstinence, or postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation. bilateral oophorectomy, or hysterectomy has been performed on the subject Exclusion Criteria: Personal / family history of allergy or hypersensitivity to olanzapine or allied drugs Past history of anaphylaxis or angioedema Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc. Any cardiac, renal or liver impairment, any other organ or system impairment History of seizure or psychiatric disorders Presence of disease markers of HIV 1 and 2, and hepatitis Band C virus Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study [one drink is equal to one unit of alcohol [ one glass Wine, half plnt boor, and one measure (one ounce) of spirit). Consumption of xanthine containing derivatives (coffee, tea, cola drinks. chocolate) within 48 hours before check-in of each period Use of any recreational drug or a history of drug addiction Participation in any clinical trial within the past 3 months Inaccessibility of veins in left and right arm Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication Receipt of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs Within the last four weeks An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and through out subject's participation in the study Consumption of grapefruit- containing food or beverages within 7 days prior to receiving the first dose of study medication in both the periods Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding Having an occupation or requirement of driving a vehicle or operate a complex machinery before 21 days of taking the drug in both periods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine OD Tablets 5 mg<br>Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited | Drug: Olanzapine OD Tablets 5 mg<br>* Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited<br>* Other names: Zyprexa Zydis;|
| Active Comparator: Zyprexa Zydis 5 mg Tablets<br>Zyprexa Zydis 5 mg Tablets of Cardinal Health, UK | Drug: Olanzapine OD Tablets 5 mg<br>* Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited<br>* Other names: Zyprexa Zydis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence is based on Cmax and AUC parameters |  | 2 months |