Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.