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Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Risperidone Orally Disintegrating Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Geatano Morelli, M.D, Principal Investigator, Affiliation: MDS Pharma Services

Summary

The purpose of this study was to assess the single-dose relative bioavailability study of 1 mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fed conditions.

Clinical Details

Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TABTM)1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers Under Fed Conditions

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

Primary outcome: Bioavailability based on Cmax and AUC parameters

Detailed description: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fed Conditions

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria: Subjects were included in the study only if they met all of the following criteria:

- Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of

age;

- Weighing at least 60 kg for males and within 15% of their ideal weights (Table of

"Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);

- Medically healthy subjects with clinically normal laboratory profiles and ECGs;

- Voluntarily consent to participate in the study.

Exclusion Criteria: Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:

- History or presence of significant cardiovascular, pulmonary, hepatic, renal,

hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.

- In addition, history or presence of:

- alcoholism or drug abuse within the past year;

- hypersensitivity or idiosyncratic reaction to risperidone or benzodiazepines or other

antipsychotic drugs;

- seizures;

- glaucoma or hypermetropia.

- Positive results on Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen

(HbsAg) and Hepatitis C Virus (HCV) Tests.

- Subjects whose sitting blood pressure is less than 110/60 mm Hg at screening or

100/55 mm Hg before dosing.

- Subjects whose pulse is lower than 55 b. p.m. at screening or 50 b. p.m. prior to

dosing. Subjects whose PR interval is ≥ 190 msec at screening and prior to dosing.

- Subjects whose aTe interval is > 450 msec at screening and prior to dosing.

- Subjects with a body temperature ≥38°C before dosing.

- Subjects who have used any drugs or substances known to be strong inhibitors of CYP

enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.

- Subjects who have used any drugs or substances known to be strong inducers of CYP

enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.

- Subjects who have been on a special diet (for whatever reason) during the 28 days

prior to the first dose and throughout the study.

- Subjects who, through completion of the study, would have donated in excess of: 500

mL of blood in 14 days, or 1500 mL of blood in 180 days, 2500 mL of blood in 1 year.

- Subjects who have participated in another clinical trial within 28 days prior to the

first dose.

Locations and Contacts

Additional Information

Starting date: August 2004
Last updated: July 1, 2010

Page last updated: August 23, 2015

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