Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition

NCT01627834 | Completed Phase 1

• 1 other identifier: 034-09
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

Conditions

Healthy

Keywords

Bioequivalence; Ropinirole Hydrochloride; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve(AUC)

  Pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 3.00,4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00,20.00, 24.00, 30.00, 36.00, 48.00 and 60.00 hours after dosing.

Study Arms (2)

Ropinirole

EXPERIMENTAL

Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited

Drug: Ropinirole

Requip

ACTIVE COMPARATOR

Requip XL Tablets 2 mg of Glaxosmithkline, USA

Drug: Ropinirole

Interventions

Ropinirole DRUG

Also known as: Requip

Requip; Ropinirole

Eligibility Criteria

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

You may qualify if:

• Healthy human subjects aged between 18 and 45 years (including both).
• Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
• Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (PIA view).
• Subjects able to communicate effectively.
• Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
• Female subjects who are postmenopausal or surgically sterile.
• Female subjects 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.

You may not qualify if:

• Subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs.
• History or presence of any medical condition or disease according to the opinion of the physician.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Systolic blood pressure less than 110mm Hg or more than 140 mm Hg.
• Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50 beats/minute or more than 100 beats/minute.
• Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.
• Donation of blood in the past 3 months before screening.
• Female subjects demonstrating a positive pregnancy screen.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

GVK Biosciences Pvt. Ltd

Ameerpet, Hyderabad, 500 038, India

Location

MeSH Terms

Interventions

ropinirole

Study Officials

• Dr. Naba Kr Talukdar, MD

  GVK Biosciences Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: October 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 28, 2012

Record last verified: 2010-01

Locations

IN (1)