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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01155934
First received: July 1, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

July 1, 2010
July 1, 2010
August 2004
August 2004   (final data collection date for primary outcome measure)
Bioavailability based on Cmax and AUC parameters [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited 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-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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
  • Experimental: Risperidone Orally Disintegrating
    Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Risperidone Orally Disintegrating Tablets
  • Active Comparator: Risperdal M-TAB
    (Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products
    Intervention: Drug: Risperidone Orally Disintegrating Tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2004
August 2004   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01155934
AA21566
Yes
Vice President, Research & Development, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Geatano Morelli, M.D MDS Pharma Services
Dr. Reddy's Laboratories Limited
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP