Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

2021 ◽  
Author(s):  
Yan‐Ying Xu ◽  
Zhi‐Heng Yi ◽  
Xiao‐Min Li ◽  
Dai Li ◽  
Lin Pan ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Bioequivalence Study ◽  
Food Effects ◽  
Oral Doses

Safety and pharmacokinetics of mifentidine after increasing oral doses in healthy subjects

1988 ◽  
Vol 35 (6) ◽  
pp. 673-676
Author(s):  
B. P. Imbimbo ◽  
M. Seiberling ◽  
U. Peuckert ◽  
G. Hoexter ◽  
H. Maier-Lenz ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Oral Doses

scholarly journals Pharmacokinetics of EDP-420 after Multiple Oral Doses in Healthy Adult Volunteers and in a Bioequivalence Study

2009 ◽  
Vol 53 (8) ◽  
pp. 3218-3225 ◽  
Author(s):  
Li-Juan Jiang ◽  
Yat Sun Or
Keyword(s):  
Systemic Exposure ◽  
Bioequivalence Study ◽  
Respiratory Pathogens ◽  
Capsule Formulation ◽  
Dose Study ◽  
Effect Of Food ◽  
Tract Infections ◽  
Oral Doses

ABSTRACT EDP-420 (also known as EP-013420, or S-013420) is a first-in-class bridged bicyclolide currently in clinical development for the treatment of respiratory tract infections (RTI) and has previously shown favorable pharmacokinetic (PK) and safety profiles after the administration of single oral doses of a suspension to healthy volunteers. Here we report its PK profile after the administration of multiple oral doses of a suspension to healthy adults. Bioequivalence between suspension and capsule formulations, as well as the effect of food, is also reported. The most important PK features of EDP-420 observed in these clinical studies are its long half-life of 17 to 18 h and its high systemic exposure, which support once-daily dosing and treatment durations potentially shorter than those of most other macrolide antibiotics. EDP-420 is readily absorbed following oral administration in both suspension and capsule formulations. In the multiple-oral-dose study, steady state was achieved on day 1 by using a loading dose of 400 mg/day, followed by 2 days of 200 mg/day. A high-fat meal had no effect on the bioavailability of EDP-420 administered in a capsule formulation. EDP-420 was well tolerated, with no serious or severe adverse events reported, and no subject was discontinued from the study due to an adverse event. Based on its human PK and safety profiles, together with its in vitro/in vivo activities against common respiratory pathogens, EDP-420 warrants further development, including trials for clinical efficacy in the treatment of RTI.

A Single-Dose, Two-Way Crossover, Bioequivalence Study of Dexmethylphenidate HCl with and without Food in Healthy Subjects

2004 ◽  
Vol 44 (2) ◽  
pp. 173-178 ◽  
Author(s):  
Steve K. Teo ◽  
Michael R. Scheffler ◽  
Anfan Wu ◽  
David I. Stirling ◽  
Steve D. Thomas ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Bioequivalence Study

Tolerance and pilot pharmacokinetics of amiflamine after increasing single oral doses in healthy subjects

1986 ◽  
Vol 40 (1) ◽  
pp. 81-85 ◽  
Author(s):  
G Alván ◽  
C Graffner ◽  
M Grind ◽  
L L Gustafsson ◽  
J E Lindgren ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Oral Doses

A single-Dose, 2-Way Crossover, Bioequivalence Study of Dexmethylphenidate With and Without Food in Healthy Subjects

2003 ◽  
Vol 73 (2) ◽  
pp. P36-P36
Author(s):  
S. Teo ◽  
M. Scheffler ◽  
D. Stirling ◽  
S. Thomas ◽  
V. Khetani
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Bioequivalence Study

Pharmacokinetics of bolus intravenous and oral doses of L-carnitine in healthy subjects

1988 ◽  
Vol 35 (1) ◽  
pp. 69-75 ◽  
Author(s):  
P. Harper ◽  
C. -E. Elwin ◽  
G. Cederblad
Keyword(s):  
Healthy Subjects ◽  
Oral Doses
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