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

NCT01503437 | Completed Phase 1 DMC

• 1 other identifier: BE-170-OLAN-2006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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 fasting conditions and to monitor adverse events and ensure safety of subjects.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence is based on Cmax and AUC parameters

  2 months

Study Arms (2)

Olanzapine OD Tablets 5 mg

EXPERIMENTAL

Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited

Drug: Olanzapine OD Tablets 5 mg

Zyprexa Zydis 5 mg Tablets

ACTIVE COMPARATOR

Zyprexa Zydis 5 mg Tablets of Cardinal Health, UK

Drug: Olanzapine OD Tablets 5 mg

Interventions

Olanzapine OD Tablets 5 mg DRUG

Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited

Also known as: Zyprexa Zydis

Olanzapine OD Tablets 5 mg; Zyprexa Zydis 5 mg Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Wellquest Clinical Research

Mumbai, Maharashtra, 400013, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Ghanashyam Rao, MBBS

  Wellquest Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 4, 2012
• Study Start: November 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IN (1)