Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions

Launched by LUPIN LTD. · Oct 25, 2012

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • i. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the written informed consent form (ICF) duly signed by the volunteer.
• • ii. Healthy human male subjects between 18-45 years Weighing at least 50 kg and with a body mass index (BMI) of 18 kg/m2 and less than or equal to 25 kg/m2 (according to the formula of BMI = weight (kg)/\[height (m)\]2).
• • iii. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 14 days prior to commencement of the study.
• • iv. Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
• • v. Light-, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months.
• Exclusion Criteria:
• History or presence of significant:
• • I. History of hypersensitivity or idiosyncratic reactions to Ropinirole or any related products.
• • II. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
• • III. Alcohol dependence, alcohol abuse or drug abuse within past one year. IV. Moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products.
• • V. History of difficulty in swallowing VI. Clinically significant illness within 4 weeks before the start of the study VII. Asthma, urticaria or other allergic type reactions after taking any medication.
• • Blood loss/donation of more than 350 mL within 3 months prior to study dosing or difficulty in donating blood.
• • Participation in another clinical study not involving donation of blood, within the preceding 90 days of study start.
• Subjects who have:
• • i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
• • ii. Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.
• • iii. Pulse rate below 50/min. or above 105/min.
• • Any waiver of these inclusion and exclusion criteria must be approved and documented by the qualified investigator and the sponsor on a case-by-case basis.