Pharmacokinetics, Bioequivalence, and Safety Studies of Pantoprazole Sodium Enteric‐Coated Tablets in Healthy Subjects

2020 ◽  
Author(s):  
Zhimin Chen ◽  
Fangliang Gan ◽  
Xiali Rao ◽  
Xiaoxiao Huang ◽  
Huafang Chen
Keyword(s):  
Healthy Subjects ◽  
Safety Studies ◽  
Enteric Coated

scholarly journals Oral bioavailability of ATP after prolonged administration

2010 ◽  
Vol 105 (3) ◽  
pp. 357-366 ◽  
Author(s):  
Erik J. C. M. Coolen ◽  
Ilja C. W. Arts ◽  
Otto Bekers ◽  
Chris Vervaet ◽  
Aalt Bast ◽  
...  
Keyword(s):  
Uric Acid ◽  
Oral Administration ◽  
Healthy Subjects ◽  
Animal Studies ◽  
Purinergic Receptors ◽  
Daily Intake ◽  
Prolonged Administration ◽  
Liver And Kidney ◽  
Enteric Coated ◽  
To Receive

Purinergic receptors are important for the regulation of inflammation, muscle contraction, neurotransmission and nociception. Extracellular ATP and its metabolites are the main ligands for these receptors. Occasional reports on beneficial results of ATP administration in human and animal studies have suggested the bioavailability of oral ATP supplements. We investigated whether prolonged daily intake of oral ATP is indeed bioavailable. Thirty-two healthy subjects were randomised to receive 0, 250, 1250 or 5000 mg ATP per d for 28 d by means of enteric-coated pellets. In addition, on days 0 and 28, all thirty-two subjects received 5000 mg ATP to determine whether prolonged administration would induce adaptations in the bioavailability of ATP. ATP supplementation for 4 weeks did not lead to changes in blood or plasma ATP concentrations. Of all ATP metabolites, only plasma uric acid levels increased significantly after the administration of 5000 mg of ATP. Prolonged administration of ATP was safe as evidenced from liver and kidney parameters. We conclude that oral administration of ATP only resulted in increased uric acid concentrations. On the basis of these findings, we seriously question the claimed efficacy of oral ATP at dosages even lower than that used in the present study.

Gastroscopic Findings after Treatment with Enteric-Coated and Plain Naproxen Tablets in Healthy Subjects

1985 ◽  
Vol 20 (2) ◽  
pp. 239-242 ◽  
Author(s):  
R. I. Trondstad ◽  
E. Aadland ◽  
T. Holler ◽  
B. Olaussen
Keyword(s):  
Healthy Subjects ◽  
Enteric Coated

Comparative Bioavailability of Enteric-Coated Aspirin Preparations

1980 ◽  
Vol 14 (2) ◽  
pp. 103-107 ◽  
Author(s):  
William J. Bicket ◽  
Susan M. Maynard ◽  
William T. Sawyer
Keyword(s):  
Salicylic Acid ◽  
Crossover Study ◽  
Drug Administration ◽  
Acid Content ◽  
Healthy Subjects ◽  
Enteric Coated Aspirin ◽  
Comparative Bioavailability ◽  
Enteric Coated

A three-way crossover study was conducted in nine healthy subjects to compare the bioavailability of one uncoated and two enteric-coated aspirin products after the administration of a single 650-mg dose of each preparation. Urine was collected at various intervals for 24 hours after drug administration and assayed for total salicylic acid content as an indicator of bioavailability. There were statistically significant differences among the three products in the amount of salicylic acid appearing in the urine, both for specific collection intervals and for cumulative (24-hour) excretions. Greater (p < 0.001) amounts of urinary salicylic acid were found in the first three hours after uncoated aspirin treatment than after enteric-coated aspirin administration. After 24 hours, equivalent amounts of salicylic acid were found following treatment with uncoated aspirin and one of the enteric-coated preparations. The absorption of aspirin from enteric-coated preparations is markedly delayed when compared to that from an uncoated product.

In vivo prostacyclin biosynthesis and effects of different aspirin regimens in patients with essential thrombocythaemia

2014 ◽  
Vol 112 (07) ◽  
pp. 118-127 ◽  
Author(s):  
Isabella Squellerio ◽  
Alfredo Dragani ◽  
Fabrizio Veglia ◽  
Francesca Pagliaccia ◽  
Benedetta Porro ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Urinary Metabolite ◽  
Essential Thrombocythaemia ◽  
Dosing Regimen ◽  
Once Daily ◽  
Enteric Coated ◽  
Platelet Thromboxane

SummaryEssential thrombocythaemia (ET) is characterised by enhanced platelet generation and thrombosis. Once daily (od) aspirin incompletely inhibits platelet thromboxane (TX)A2 production in ET. A twice daily (bid) dosing is necessary to fully inhibit TXA2. Whether this dosing regimen affects in vivo prostacyclin (PGI2) biosynthesis is unknown. PGI2 biosynthesis was characterised in 50 ET patients on enteric-coated (EC) aspirin 100 mg od, by measuring its urinary metabolite, 2,3-dinor-6-keto-PGF1α (PGI-M). Moreover, in a crossover study 22 patients poorly responsive to standard aspirin based on serum TXB2 levels (>4 ng/ml) were randomised to different seven-day aspirin regimens: EC aspirin 100 mg od, 100 mg bid, 200 mg od, or plain as-pirin 100 mg od. PGI-M measured 24 hours after the last aspirin intake (EC, 100 mg od) was similar in patients and healthy subjects both on (n=10) and off (n=30) aspirin. PGI-M was unrelated to in vivo TXA2 biosynthesis, and not affected by EC aspirin 100 mg bid or 200 mg od as compared to EC 100 mg od. PGI2 biosynthesis in aspirin-treated ET patients appears unrelated to TXA2 biosynthesis, and not affected by an improved aspirin regimen, demonstrating its vascular safety for future trials.

Combined scintigraphic and pharmacokinetic investigation of enteric-coated mesalazine micropellets in healthy subjects

2003 ◽  
Vol 17 (9) ◽  
pp. 1153-1162 ◽  
Author(s):  
I. R. Wilding ◽  
C. Behrens ◽  
S. J. Tardif ◽  
H. Wray ◽  
P. Bias ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Pharmacokinetic Investigation ◽  
Enteric Coated

Reflex Responses in Upper Limb Muscles to Cutaneous Stimuli

1993 ◽  
Vol 20 (04) ◽  
pp. 271-278 ◽  
Author(s):  
R. Chen
Keyword(s):  
Stimulus Intensity ◽  
Upper Limb ◽  
Healthy Subjects ◽  
Voluntary Contraction ◽  
Cutaneous Reflexes ◽  
Focal Lesions ◽  
Normal Ranges ◽  
Conduction Velocities ◽  
Limb Muscles ◽  
Biphasic Responses

ABSTRACT:Cutaneous reflexes in the upper limb were elicited by stimulating digital nerves and recorded by averaging rectified EMG from proximal and distal upper limb muscles during voluntary contraction. Distal muscles often showed a triphasic response: an inhibition with onset about 50 ms (Il) followed by a facilitation with onset about 60 ms (E2) followed by another inhibition with onset about 80 ms (12). Proximal muscles generally showed biphasic responses beginning with facilitation or inhibition with onset at about 40 ms. Normal ranges for the amplitude of these components were established from recordings on 22 arms of 11 healthy subjects. An attempt was made to determine the alterent fibers responsible for the various components by varying the stimulus intensity, by causing ischemic block of larger fibers and by estimating the afferent conduction velocities. The central pathways mediating these reflexes were examined by estimating central delays and by studying patients with focal lesions

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