NCT01712568

Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets

AN OPEN LABEL, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, BIOEQUIVALENCE STUDY OF ROPINIROLE HYDROCHLORIDE CR 2mg TABLETS OF LUPIN LIMITED, INDIA, COMPARING WITH THAT OF REQUIP XL OF GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, IN HEALTHY ADULT MALE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lupin Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel. The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.

Conditions

• Pharmacokinetic Study

Interventions

Type	Name	Description
DRUG	Test Product (Ropinirole)	one Tablet at "0" hour
DRUG	Reference Product (REQUIP )	one Tablet at "0" hour

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2012-10-23
• Last updated: 2012-10-23

Locations

1 site across 1 country: India