Bioequivalence Study of Risperidone 1.0 mg Tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fasting Conditions

NCT00939497 | Completed Phase 1

• 1 other identifier: 1119/07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective:

• To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical Products, LP, USA, in healthy human adult subjects, under fasting conditions. Study Design:
• A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Interventions

Risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy human adult subjects between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
• Subjects who have no evidence of underlying disease during screening history and whose physical examination is performed within 21 days prior to commencement of the study.
• Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
• Informed consent given in written form according to section 11.3 of the protocol.
• Female Subjects:
• Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• Postmenopausal for at least 1 year.
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• History or presence of significant:
• Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
• Alcohol dependence, alcohol abuse or drug abuse within past one year.
• Moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products.
• History of difficulty in swallowing tablet / capsule.
• Clinically significant illness within 4 weeks before the start of the study
• Asthma, urticaria or other allergic type reactions after taking any medication.
• Positive urine drug screening, HIV, Hepatitis B \& C tests.
• Any history of hypersensitivity to Risperidone.
• Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
• Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development / impaired cerebral function.
• Subject who has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks prior to the start of the study.
• Subjects who have:
• Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg.
• Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Lotus Labs Pvt. Ltd.

Bangalore, Karnataka, 560 052, India

Location

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 15, 2009
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

IN (1)