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

NCT ID: NCT01155934

Last Updated: 2010-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2004-08-31

Brief 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.

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risperidone Orally Disintegrating

Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Risperidone Orally Disintegrating Tablets

Intervention Type: DRUG

Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited

Risperdal M-TAB

(Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products

Group Type: ACTIVE_COMPARATOR

Risperidone Orally Disintegrating Tablets

Intervention Type: DRUG

Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited

Interventions

Risperidone Orally Disintegrating Tablets

Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited

Intervention Type: DRUG

Other Intervention Names

(Risperdal M-TAB) tablets of Janssen Pharmaceutica Products

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Geatano Morelli, M.D

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Other Identifiers

AA21566

Identifier Type: -

Identifier Source: org_study_id