Overview

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

Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
0
Participant gender:
Male
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 fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Risperidone
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.