scholarly journals The Absolute Bioavailability of Desvenlafaxine in Healthy Subjects

2012 ◽  
Vol 04 (02) ◽  
Author(s):  
Alice I Nichols ◽  
Jessica A Behrle ◽  
Lyette S Richards
Keyword(s):  
Healthy Subjects ◽  
Absolute Bioavailability ◽  
The Absolute

scholarly journals A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach

2019 ◽  
Vol 8 (1) ◽  
pp. 91-102
Author(s):  
Xiaomin Wang ◽  
Jian Chen ◽  
Josephine Reyes ◽  
Simon Zhou ◽  
Maria Palmisano ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Phase 1 ◽  
Absolute Bioavailability ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
The Absolute

scholarly journals T-cell activation and subset patterns are altered in B-CLL and correlate with the stage of the disease

Blood ◽  
1989 ◽  
Vol 74 (2) ◽  
pp. 786-792 ◽  
Author(s):  
TH Totterman ◽  
M Carlsson ◽  
B Simonsson ◽  
M Bengtsson ◽  
K Nilsson
Keyword(s):  
T Cells ◽  
T Cell ◽  
T Cell Activation ◽  
Healthy Subjects ◽  
Lymphocytic Leukemia ◽  
Stage Ii ◽  
T Cell Subsets ◽  
Cd8 Cells ◽  
Hla Dr ◽  
The Absolute

Abstract Two-color FACS analysis was used to study activated and “functional” T and natural killer (NK) cell subsets of circulating lymphocytes in 23 patients with B-type chronic lymphocytic leukemia (B-CLL) and in 30 healthy subjects. As compared with controls, B-CLL patients had increased absolute numbers of phenotypically activated, HLA-DR+ CD4+ and CD8+ cells and T suppressor/effector (CD11b+CD8+) cells. When patients in Rai stages II through IV (n = 11) were compared with cases in Rai stages O through I (n = 12), the former group of patients had higher numbers of activated CD4+ and CD8+ T cells and decreased levels of suppressor/effector T cells. The absolute numbers of T suppressor/inducer (CD45R+CD4+) cells were elevated in patients with stage O through I disease but within normal range in stage II through IV leukemia. We further showed that the absolute numbers of NK-like (CD16+) cells and their activated counterparts (DR+CD16+) are elevated in B-CLL patients as compared with healthy subjects. The comparison of relative T and NK subsets in the blood of patients and controls showed that the proportions of CD4+, CD8+, and CD16+ cells expressing the activation marker HLA-DR were increased in B-CLL. Furthermore, the percentage of T-suppressor/inducer (CD45R+) cells within the CD4+ population was decreased in the patients. The proportion of T- suppressor/effector (CD11b+) cells within the CD8+ subset was reduced in subjects with stage II-IV disease only. When stimulated in vitro with the T-cell-dependent inducer TPA, B-CLL cells from patients in Rai stages II through IV secreted larger amounts of IgM as compared with cells from stage O through I patients. A positive correlation was observed between the degree of phenotypic activation of CD4+ T-helper cells and their functional capacity to augment IgM secretion by autologous B-CLL cells. Our findings indicate a tumor cell-directed regulatory role of T cells (and possibly NK cells as well) in B-CLL. Furthermore, monitoring of phenotypically activated and functional T- cell subsets may be helpful in the prediction of disease progression and timing of therapy in B-CLL.

The absolute bioavailability of microcrystalline theophylline

1979 ◽  
Vol 6 (sup6) ◽  
pp. 71-76 ◽  
Author(s):  
J. H. G. Jonkman ◽  
W. Chr. Berg ◽  
R. Schoenmaker ◽  
J. E. Graving ◽  
R. A. Dezeeuw ◽  
...  
Keyword(s):  
Absolute Bioavailability ◽  
The Absolute

scholarly journals A Randomized, Open-label Study of the Pharmacokinetics and Safety of Oral and Intravenous Administration of Omadacycline to Healthy Subjects

2016 ◽  
pp. AAC.01393-16 ◽  
Author(s):  
Haiying Sun ◽  
Lillian Ting ◽  
Surendra Machineni ◽  
Jens Praestgaard ◽  
Andreas Kuemmell ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Geometric Mean ◽  
Oral Solution ◽  
Tablet Formulation ◽  
Absolute Bioavailability ◽  
Open Label ◽  
Phase 3 ◽  
Total Exposure ◽  
Oral Formulations ◽  
Tablet Formulations

Omadacycline is a first in class aminomethylcycline antibiotic with microbiological activity against Gram-positive and Gram-negative aerobes and anaerobes, and atypical bacteria that is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The bioavailability of a Phase 3 tablet formulation relative to intravenous (IV) administration (and of other oral formulations relative to the Phase 3 tablet) was investigated in an open-label, randomized, four-period, crossover study in healthy subjects age 18-50 years. Subjects received omadacycline 100 mg IV, 300 mg oral as two different tablet formulations with different dissolution profiles, and a 300 mg as an oral solution. Plasma omadacycline concentrations were determined using a validated LC/MS/MS method. Twenty of 24 subjects completed all treatment periods. Both tablet formulations produced equivalent total exposure relative to each other. The Phase 3 tablet produced equivalent exposure to the 100 mg IV dose with geometric mean ratio (90% confidence intervals [CI]) for AUCinfof 1.00 (0.93,1.07). Absolute bioavailability of the tablets was approximately 34.5%. Intersubject variability was consistent among the oral formulations (∼20-25%). Single oral and IV doses of omadacycline were well tolerated; three subjects experienced mild adverse events (dizziness, nausea, vomiting) that resolved without intervention. A 300 mg dose of the tablet formulation of omadacycline intended for use in phase 3 studies produced total exposure equivalent to that of a 100 mg IV dose.

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