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.