Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Risperidone Orally Disintegrating Tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Geatano Morelli, M.D, Principal Investigator, Affiliation: MDS Pharma Services
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.
Clinical Details
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 Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioavailability based on Cmax and AUC parameters
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 Fasting Conditions
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
Additional Information
Starting date: August 2004
Last updated: July 1, 2010
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