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

NCT01155921 | Completed Phase 1 DMC

• 1 other identifier: AA19885
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 fasting conditions.

Conditions

Healthy

Keywords

Bioavailability; Crossover; Risperidone

Outcome Measures

Primary Outcomes (1)

• Bioavailability based on Cmax and AUC parameters

  1 Month

Study Arms (2)

Risperidone Orally Disintegrating

EXPERIMENTAL

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

Drug: Risperidone Orally Disintegrating Tablets

Risperdal M-TAB

ACTIVE COMPARATOR

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

Drug: Risperidone Orally Disintegrating Tablets

Interventions

Risperidone Orally Disintegrating Tablets DRUG

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

Also known as: (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products

Risperdal M-TAB; Risperidone Orally Disintegrating

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Geatano Morelli, M.D

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: August 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: July 2, 2010

Record last verified: 2010-07