Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01503424
Other study ID # 379-11
Secondary ID
Status Completed
Phase Phase 1
First received January 2, 2012
Last updated January 4, 2012
Start date August 2011
Est. completion date September 2011

Study information

Verified date January 2012
Source Dr. Reddy's Laboratories Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse events and ensure the safety of the subjects.


Description:

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and Company, USA, in healthy, adult, human subjects under fed conditions.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy, adult, human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of IndIa.

- Having a Body Mass Index (BMI) between 18.5 and 24.9(both inclusive), calculated as weight in kg/height in m2.

- Non-smokers since at least six months.

- Have no significant diseases or clinically significant abnormal findings during screening,medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.

- Able to understand and comply with the study procedures. in the opinion of the Principal investigator.

- Able to give voluntary written informed consent for participation in the trial.

- In case of female subjects:

- Surgically sterilized at least 6 months prior to study participation or

- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.

- Pregnancy test must be negative.

Exclusion Criteria:

- Known hypersensitivity or idiosyncratic reaction to olanzapine to any of its excipients or any drug or any substance.

- History or presence of any disease or condition which might compromise the haemopoietic,renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

- A recent history of harmful use of alcohol(less than 2 years),ie alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hrs prior to receiving IMP.

- Inability to remain in an upright position at the time of dosing.

- Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at the time of screening.

- Presence of orthostatic hypotension at the time of screening.

- Ingestion or Use of any medication at any time within l4 days prior to dosing in period-1. In any such case subject selection will be at the discretion of the Principal Investigator.

- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAII)induced urticaria.

- Consumption of Grape fruits or its products within a period of 48 hours prior to receiving the study drug.

- The presence of clinically significant abnormal laboratory values during screening.

- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.

- History or presence of psychiatric disorders.

- A history of difficulty with donating blood.

- Donation of blood (l unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.

Note: In case the blood loss is = 200 mL; subject may be enrolled 60 days after blood donation or last sample of the previous study.

- A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.

- A positive test result for HIV antibody.

- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator.

- Nursing mothers (females).

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Olanzapine
Olanzapine Tablets, 5 mg

Locations

Country Name City State
India Lambda Therapeutic Research Ltd., Ahmedabad Gujrat

Sponsors (1)

Lead Sponsor Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence is based on Cmax and AUC parameters 2 months No
See also
  Status Clinical Trial Phase
Completed NCT01827878 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions Phase 1
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A
Completed NCT01372306 - Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition Phase 1
Completed NCT01283932 - Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition Phase 1
Completed NCT03390881 - Use of Breath Acetone aa a Marker of Energy Balance N/A
Completed NCT01283867 - Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions Phase 1
Completed NCT01503450 - Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition Phase 1
Completed NCT01735383 - Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition Phase 1
Completed NCT01618760 - Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition Phase 1
Completed NCT01578265 - Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition Phase 1
Recruiting NCT05837572 - Development of the Leeds Food Preference Questionnaire in Spanish N/A
Completed NCT01618825 - Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition Phase 1
Completed NCT01505998 - Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions Phase 1
Completed NCT01735344 - Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition Phase 1
Completed NCT01372358 - Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Non-Fasting Conditions Phase 1
Completed NCT01567501 - Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition Phase 1
Completed NCT05995119 - Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers Early Phase 1
Completed NCT01314352 - Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions Phase 1
Completed NCT01744873 - Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition Phase 1
Completed NCT01884909 - Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions Phase 1