An open-label, multiple-dose study to assess the preliminary pharmacokinetics, pharmacodynamics, clinical activity, and safety of human mouse chimeric anti-CD22 monoclonal antibody (SM03) in patients with rheumatoid arthritis

2021 ◽  
Author(s):  
Qian Zhao ◽  
Xia Chen ◽  
Ji Jiang ◽  
Jing Li ◽  
Wen Zhong ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Monoclonal Antibody ◽  
Multiple Dose ◽  
Clinical Activity ◽  
Open Label ◽  
Multiple Dose Study ◽  
Dose Study

scholarly journals Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: An open-label, parallel-arm, multiple-dose study

2013 ◽  
Vol 150 (1) ◽  
pp. 281-288 ◽  
Author(s):  
Suresh Mallikaarjun ◽  
John M. Kane ◽  
Patricia Bricmont ◽  
Robert McQuade ◽  
William Carson ◽  
...  
Keyword(s):  
Multiple Dose ◽  
Open Label ◽  
Multiple Dose Study ◽  
Dose Study

scholarly journals Lack of Effect of Efavirenz on the Pharmacokinetics of Tipranavir-Ritonavir in Healthy Volunteers

2009 ◽  
Vol 53 (11) ◽  
pp. 4840-4844 ◽  
Author(s):  
C. J. L. la Porte ◽  
J. P. Sabo ◽  
L. Béïque ◽  
D. W. Cameron
Keyword(s):  
Steady State ◽  
Multiple Dose ◽  
Healthy Adult ◽  
Geometric Mean ◽  
Plasma Concentrations ◽  
Open Label ◽  
Multiple Dose Study ◽  
Chromatography Tandem Mass Spectrometry ◽  
Liquid Chromatography Tandem Mass ◽  
Dose Study

ABSTRACT Previously it has been shown that tipranavir-ritonavir (TPV/r) does not affect efavirenz (EFV) plasma concentrations. This study investigates the effect of steady-state EFV on steady-state TPV/r pharmacokinetics. This was a single-center, open-label, multiple-dose study of healthy adult female and male volunteers. TPV/r 500/200 mg twice a day (BID) was given with food for 24 days. After dosing with TPV/r for 10 days, EFV 600 mg once a day was added to the regimen. Intensive pharmacokinetic (PK) sampling was done on days 10 and 24. Validated bioanalytical high-pressure liquid chromatography-tandem mass spectrometry methods were used to determine plasma tipranavir (TPV), ritonavir (RTV), and EFV concentrations. Thirty-four subjects were entered into the study, and 16 subjects completed it. The geometric mean ratios (90% confidence intervals) for TPV and RTV area under the curves, C maxs, and C mins comparing TPV/r alone and in combination with EFV were 0.97 (0.87 to 1.09), 0.92 (0.81 to 1.03), and 1.19 (0.93 to 1.54) for TPV and 1.03 (0.78 to 1.38), 0.92 (0.65 to 1.30), and 1.04 (0.72 to 1.48) for RTV. Frequently observed adverse events were diarrhea, headache, dizziness, abnormal dreams, and rash. EFV had no effect on the steady-state PK of TPV or RTV, with the exception of a 19% increase in the TPV C min, which is not clinically relevant. TPV/r can be safely coadministered with EFV and without the need for a dose adjustment.

Pharmacokinetics and tolerability of cinitapride in healthy Chinese volunteers: a randomized, open-label, single- and multiple-dose study

Xenobiotica ◽  
2018 ◽  
Vol 49 (3) ◽  
pp. 313-321
Author(s):  
Xiong Zhang ◽  
Ying Wang ◽  
Junlin Cheng ◽  
Yunfang Hu ◽  
Jianghui Liu ◽  
...  
Keyword(s):  
Multiple Dose ◽  
Open Label ◽  
Multiple Dose Study ◽  
Dose Study ◽  
Healthy Chinese
Sign in / Sign up

Export Citation Format

Share Document