View clinical trials related to Pharmacokinetic Study.
Filter by:This is a single-center, open-label, fixed sequence phase I clinical study. To evaluate the effect of continuous administration of omeprazole magnesium enteric coated tablets on PK after single dose AB-106 capsule administration in Chinese healthy male subjects. This study includes a screening period (1-28 days before administration), treatment period (34 days), and follow-up period ( after the last dose completed 7 ± 3 days). The treatment period of this study was divided into two periods, and the subjects were divided into two groups, 12 subjects in the first group and 10 subjects in the second group. The treatment method and research process of each group of subjects are the same. After the first group of subjects completes the second cycle and is evaluated by the investigator and sponsor, the second group of subjects can start administration. If there are no more than 4 subjects in the first group who have vomiting gastrointestinal reaction (vomiting occurs within 8 hours after each cycle of administration) after completing the two cycles of administration of AB-106 400 mg, they can be added to the second group of subjects, and the number of added subjects shall not exceed the number of subjects who have vomiting gastrointestinal reaction. If more than 4 subjects have gastrointestinal reaction of vomiting, the investigator and sponsor will make a comprehensive evaluation, and can reduce the dosage of AB-106 to 200 mg, and 22 subjects will be included in the trial at one time or supplemented in the second group to complete the 400 mg dose group
Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.
A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese 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 30 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.
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 30 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 after consuming the whole standardized high fat non-veg breakfast. 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, 6.00, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 11.50, 12.00, 12.50, 13.00, 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.
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.