Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01503398
• Date of registration: 02/01/2012
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
• Scientific title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Olanzapine Tablets 5 mg With Zyprexa® Tablets 5 mg in Healthy Subjects Under Fasting Conditions
• Date of first enrolment: August 2011
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01503398
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Vipul Chaudhary, MD
• Affiliation: Lambda Therapeutic Research Ltd.,

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fasting

Intervention(s)

Drug: Olanzapine

Primary Outcome(s)

Bioequivalence is based on Cmax and AUC parameters [Time Frame: 2 months]

Secondary ID(s)

378-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors