scholarly journals Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers

2018 ◽  
Vol 8 (6) ◽  
pp. 702-712 ◽  
Author(s):  
Naoki Kotani ◽  
Koichiro Yoneyama ◽  
Nobuhiko Kawakami ◽  
Tohru Shimuta ◽  
Hiroyuki Fukase ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Subcutaneous Injection ◽  
Absolute Bioavailability ◽  
Drug Products ◽  
Bioavailability Study

P1156 DACLATASVIR, ASUNAPREVIR, AND BMS-791325 IN A FIXED-DOSE COMBINATION: A PHASE 1 BIOAVAILABILITY STUDY IN HEALTHY VOLUNTEERS

2014 ◽  
Vol 60 (1) ◽  
pp. S468-S469 ◽  
Author(s):  
R. Adamczyk ◽  
K. Sims ◽  
I. Chang ◽  
D. Filoramo ◽  
J. Pursley ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Phase 1 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Bioavailability Study ◽  
Dose Combination

Bioavailability Study of Two Oral Formulations of Didanosine in Healthy Volunteers

2011 ◽  
Vol 56 (05) ◽  
pp. 359-364
Author(s):  
Simone Andrade ◽  
Eunice Kano ◽  
Tatiane de Lima Souza Brioschi ◽  
Eunice Koono ◽  
Cristina Serra ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Oral Formulations ◽  
Bioavailability Study

scholarly journals Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors

2001 ◽  
Vol 12 (11) ◽  
pp. 1643-1649 ◽  
Author(s):  
M. Marty ◽  
P. Fumoleau ◽  
A. Adenis ◽  
Y. Rousseau ◽  
Y. Merrouche ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Absolute Bioavailability ◽  
Oral Vinorelbine ◽  
Bioavailability Study

scholarly journals Nasal Administration and Plasma Pharmacokinetics of Parathyroid Hormone Peptide PTH 1-34 for the Treatment of Osteoporosis

Pharmaceutics ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 265 ◽  
Author(s):  
Richard G. Pearson ◽  
Tahir Masud ◽  
Elaine Blackshaw ◽  
Andrew Naylor ◽  
Michael Hinchcliffe ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Subcutaneous Injection ◽  
Relative Bioavailability ◽  
Nasal Delivery ◽  
Absolute Bioavailability ◽  
Preclinical Model ◽  
Permeation Enhancer ◽  
Treatment Of Osteoporosis ◽  
Plasma Pharmacokinetics ◽  
Spray Formulation

Nasal delivery of large peptides such as parathyroid 1-34 (PTH 1-34) can benefit from a permeation enhancer to promote absorption across the nasal mucosa into the bloodstream. Previously, we have published an encouraging bioavailability (78%), relative to subcutaneous injection in a small animal preclinical model, for a liquid nasal spray formulation containing the permeation enhancer polyethylene glycol (15)-hydroxystearate (Solutol® HS15). We report here the plasma pharmacokinetics of PTH 1-34 in healthy human volunteers receiving the liquid nasal spray formulation containing Solutol® HS15. For comparison, data for a commercially manufactured teriparatide formulation delivered via subcutaneous injection pen are also presented. Tc-99m-DTPA gamma scintigraphy monitored the deposition of the nasal spray in the nasal cavity and clearance via the inferior meatus and nasopharynx. The 50% clearance time was 17.8 min (minimum 10.9, maximum 74.3 min). For PTH 1-34, mean plasma Cmax of 5 pg/mL and 253 pg/mL were obtained for the nasal spray and subcutaneous injection respectively; relative bioavailability of the nasal spray was ≤1%. Subsequently, we investigated the pharmacokinetics of the liquid nasal spray formulation as well as a dry powder nasal formulation also containing Solutol® HS15 in a crossover study in an established ovine model. In this preclinical model, the relative bioavailability of liquid and powder nasal formulations was 1.4% and 1.0% respectively. The absolute bioavailability of subcutaneously administered PTH 1-34 (mean 77%, range 55–108%) in sheep was in agreement with published human data for teriparatide (up to 95%). These findings have important implications in the search for alternative routes of administration of peptides for the treatment of osteoporosis, and in terms of improving translation from animal models to humans.

Absolute bioavailability of oral immediate and slow release fluphenazine in healthy volunteers

1996 ◽  
Vol 51 (2) ◽  
pp. 183-187 ◽  
Author(s):  
R. Koytchev ◽  
R.-G. Alken ◽  
G. McKay ◽  
T. Katzarov
Keyword(s):  
Healthy Volunteers ◽  
Slow Release ◽  
Absolute Bioavailability

Absolute Bioavailability of Ceftriaxone after Intramuscular Administration to Healthy Volunteers

Chemotherapy ◽  
1983 ◽  
Vol 29 (3) ◽  
pp. 157-162 ◽  
Author(s):  
R. Delsignore ◽  
C.M. Baroni ◽  
G. Crotti ◽  
F. Mineo ◽  
U. Butturini ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Intramuscular Administration ◽  
Absolute Bioavailability
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