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

• ClinicalTrials.gov Identifier: NCT01155934
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by: Dr. Reddy's Laboratories Limited

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Risperidone Orally Disintegrating Tablets	Phase 1

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: August 2004
• Actual Primary Completion Date: August 2004
• Actual Study Completion Date: August 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: Risperidone Orally Disintegrating; Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited	Drug: Risperidone Orally Disintegrating Tablets; Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited; Other Name: (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products
Active Comparator: Risperdal M-TAB; (Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products	Drug: Risperidone Orally Disintegrating Tablets; Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited; Other Name: (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products

Outcome Measures

Primary Outcome Measures :

1. Bioavailability based on Cmax and AUC parameters [ Time Frame: 1 Month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Geatano Morelli, M.D; MDS Pharma Services

More Information

• Responsible Party: Vice President, Research & Development, Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT01155934
• Other Study ID Numbers: AA21566
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Last Verified: July 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Bioavailability; Crossover; Risperidone

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents