Abstract LB-198: A phase I open-label fixed-sequence two-period crossover study of the effect of multiple doses of modafinil on palbociclib (PD–0332991) pharmacokinetics in healthy volunteers

2016 ◽  
Author(s):  
Justin T. Hoffman ◽  
Cho-Ming Loi ◽  
Anna Plotka ◽  
Melissa O’Gorman ◽  
Haihong Shi ◽  
...  
Keyword(s):  
Phase I ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Open Label ◽  
Fixed Sequence ◽  
Multiple Doses

Effect of Steady-State Faldaprevir on Pharmacokinetics of Atorvastatin or Rosuvastatin in Healthy Volunteers: A Prospective Open-Label, Fixed-Sequence Crossover Study

2017 ◽  
Vol 57 (10) ◽  
pp. 1305-1314 ◽  
Author(s):  
Fenglei Huang ◽  
Kristell Marzin ◽  
Rüdiger Koenen ◽  
Klaus Peter Kammerer ◽  
Natalja Strelkowa ◽  
...  
Keyword(s):  
Steady State ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Open Label ◽  
Fixed Sequence

scholarly journals Pharmacokinetic Interaction between Faldaprevir and Cyclosporine or Tacrolimus in Healthy Volunteers: A Prospective, Open-Label, Fixed-Sequence, Crossover Study

2018 ◽  
Vol 123 (1) ◽  
pp. 84-93 ◽  
Author(s):  
Fenglei Huang ◽  
Claudia Voelk ◽  
Matthias Trampisch ◽  
Lois Rowland ◽  
Armin Schultz ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Volunteers ◽  
Pharmacokinetic Interaction ◽  
Open Label ◽  
Fixed Sequence

scholarly journals Bioequivalence of intramuscular and subcutaneous peginterferon beta-1a: results of a phase I, open-label crossover study in healthy volunteers

2021 ◽  
Vol 14 ◽  
pp. 175628642097522
Author(s):  
Yuan Zhao ◽  
Kun Chen ◽  
Nancy Ramia ◽  
Sangeeta Sahu ◽  
Achint Kumar ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Phase I ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Treatment Option ◽  
Area Under The Curve ◽  
Open Label ◽  
Post Dose ◽  
Maximum Serum ◽  
Alternative Treatment Option

Background: Peginterferon beta-1a administered every 2 weeks via subcutaneous (SC) injection is approved to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) and relapsing forms of multiple sclerosis (RMS). However, associated injection site reactions (ISRs) can lead to treatment discontinuation. Prior studies with interferon beta-1a reported a lower frequency of ISRs with intramuscular (IM) administration than with SC administration. IM administration of peginterferon beta-1a may therefore represent a useful alternative treatment option. Methods: A phase I, open-label, two-period crossover study randomized healthy volunteers to receive a single dose of peginterferon beta-1a 125 mcg administered IM followed by a single 125 mcg dose administered SC after a 28-day washout or vice versa. Blood samples were collected up to 504 h post dose to determine pharmacokinetic (PK) and pharmacodynamic (PD) profiles. The primary endpoint was assessment of bioequivalence based on maximum serum concentration (Cmax) and area under the curve from time zero extrapolated to infinity (AUCinf). Other PK parameters, as well as PD (serum neopterin) and safety profiles, were also evaluated. Results: The study enrolled 136 participants. Bioequivalence of IM and SC peginterferon beta-1a was established for both Cmax ([least squares (LS)] mean IM/SC ratio: 1.083 [90% confidence interval (CI), 0.975–1.203]) and AUCinf (LS mean IM/SC ratio: 1.089 [90% CI, 1.020–1.162]). Other PK and PD parameters were similar between administration routes, although moderate to high inter-subject variability was observed for IM and SC. Safety profiles were generally balanced between IM and SC administration. ISRs occurred at a lower frequency with IM [14.4% (95% CI, 8.89–21.56%)] than with SC [32.1% (95% CI, 24.29–40.70%)] administration ( p = 0.0005). Conclusions: These results demonstrate bioequivalence between peginterferon beta-1a IM and SC and support the consideration of IM injection of peginterferon beta-1a as a viable treatment option in patients with RRMS and RMS.

Effects of oral posaconazole on the pharmacokinetic properties of oral and intravenous midazolam: A phase I, randomized, open-label, crossover study in healthy volunteers

2009 ◽  
Vol 31 (2) ◽  
pp. 286-298 ◽  
Author(s):  
Gopal Krishna ◽  
Allen Moton ◽  
Lei Ma ◽  
Ishani Savant ◽  
Monika Martinho ◽  
...  
Keyword(s):  
Phase I ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Open Label ◽  
Pharmacokinetic Properties

Abstract 4515: A phase 1 randomized, open-label, fixed-sequence, 2-period study of the effect of multiple doses of rifampin on palbociclib (PD-0332991) pharmacokinetics in healthy volunteers

2015 ◽  
Author(s):  
Justin T. Hoffman ◽  
Anna Plotka ◽  
Melissa O'Gorman ◽  
Andrew Chang ◽  
Maha Kosa ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Phase 1 ◽  
Open Label ◽  
Fixed Sequence ◽  
Multiple Doses

scholarly journals A Phase 1 Open-Label Fixed-Sequence Two-Period Crossover Study of the Effect of Multiple Doses of Tamoxifen on Palbociclib (PD-0332991) Pharmacokinetics in Healthy Male Volunteers

2014 ◽  
Vol 25 ◽  
pp. i25 ◽  
Author(s):  
J.T. Hoffman ◽  
M. O'Gorman ◽  
C. Loi ◽  
A. Plotka ◽  
L. Kirkovsky ◽  
...  
Keyword(s):  
Crossover Study ◽  
Phase 1 ◽  
Healthy Male ◽  
Open Label ◽  
Fixed Sequence ◽  
Healthy Male Volunteers ◽  
Male Volunteers ◽  
Multiple Doses

Pharmacokinetics and Safety of Coadministered Oseltamivir and Rimantadine in Healthy Volunteers: An Open-Label, Multiple-Dose, Randomized, Crossover Study

2012 ◽  
Vol 52 (8) ◽  
pp. 1255-1264 ◽  
Author(s):  
Georgina Cirrincione-Dall ◽  
Barbara J. Brennan ◽  
Rosa M. Ballester-Sanchis ◽  
Mercidita T. Navarro ◽  
Brian E. Davies
Keyword(s):  
Crossover Study ◽  
Healthy Volunteers ◽  
Multiple Dose ◽  
Open Label ◽  
Randomized Crossover Study
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