NCT01155921CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 36
- Primary Endpoint
- Bioavailability based on Cmax and AUC parameters
Study Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Risperdal M-TAB
Active Comparator
(Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products
Intervention: Risperidone Orally Disintegrating Tablets (Drug)
Risperidone Orally Disintegrating
Experimental
Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
Intervention: Risperidone Orally Disintegrating Tablets (Drug)
Outcomes
Primary Outcomes
Bioavailability based on Cmax and AUC parameters
Time Frame: 1 Month
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 1
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed ConditionsHealthyNCT01155934Dr. Reddy's Laboratories Limited36
Completed
Phase 1
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) ConditionsHealthyNCT01155908Dr. Reddy's Laboratories Limited48
Completed
Phase 1
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting ConditionsHealthyNCT01155895Dr. Reddy's Laboratories Limited54
Completed
Phase 1
Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting ConditionHealthyNCT01133444Dr. Reddy's Laboratories Limited24
Completed
Phase 1
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed ConditionHealthyNCT01133457Dr. Reddy's Laboratories Limited24