Pharmacokinetic Study Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01714856 -
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
|
Phase 1 | |
| Completed |
NCT01717235 -
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 Fasting Conditions
|
Phase 1 | |
| Completed |
NCT04613999 -
A Study of Ralinepag in Healthy Chinese Adult Subjects
|
Phase 1 | |
| Completed |
NCT05609929 -
Study the Effect of Omeprazole on AB-106 Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT04804904 -
A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04788810 -
Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
|
N/A |