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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Ropinirole

About this trial

This is an interventional treatment trial for Healthy focused on measuring Bioequivalence, Ropinirole Hydrochloride, crossover

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Female subjects who are currently breast-feeding.
Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).

Sites / Locations

GVK Biosciences Pvt. Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ropinirole

Requip

Arm Description

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

Requip XL Tablets 2 mg of Glaxosmithkline, USA

Outcomes

Primary Outcome Measures

Area under curve(AUC)

Secondary Outcome Measures

Full Information

NCT ID

NCT01627847

First Posted

June 22, 2012

Last Updated

September 27, 2012

Sponsor

Dr. Reddy's Laboratories Limited

1. Study Identification

Unique Protocol Identification Number

NCT01627847

Brief Title

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

Official Title

Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Oral Bioequivalence Study of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India With REQUIP@ XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in Normal, Healthy, Adult, Human Subjects Under Fed Condition.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

The objective of this study was to determine the single-dose oral bioequivalence of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India with REQUIP® XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fed condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Bioequivalence, Ropinirole Hydrochloride, crossover

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ropinirole

Arm Type

Experimental

Arm Description

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

Arm Title

Requip

Arm Type

Active Comparator

Arm Description

Requip XL Tablets 2 mg of Glaxosmithkline, USA

Intervention Type

Drug

Intervention Name(s)

Ropinirole

Other Intervention Name(s)

Requip

Primary Outcome Measure Information:

Title

Area under curve(AUC)

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Female subjects who are currently breast-feeding. Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Naba Kr Talukdar, MD

Organizational Affiliation

GVK Biosciences Pvt. Ltd.

Official's Role

Principal Investigator

Facility Information:

Facility Name

GVK Biosciences Pvt. Ltd

City

Ameerpet

State/Province

Hyderabad, Andhra Pradesh

ZIP/Postal Code

500 038

Country

India

12. IPD Sharing Statement

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

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