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

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”

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.

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Risperidone Orally Disintegrating
  • Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
• Active Comparator: Risperdal M-TAB
  • (Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products

Primary Measures

• Bioavailability based on Cmax and AUC parameters
  • Time Frame: 1 Month
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Dr. Reddy's Laboratories Limited Industry

Overall Clinical Trial Officials and Contacts

Geatano Morelli, M.D Principal Investigator MDS Pharma Services  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01155934

Study ID Number: AA21566

ClinicalTrials.gov Identifier: NCT01155934

Health Authority: United States: Food and Drug Administration