Pharmacokinetic properties of isradipine after single-dose and multiple-dose oral administration in Chinese volunteers: a randomized, open-label, parallel-group phase I study

2013 ◽  
Vol 27 (12) ◽  
pp. 1664-1670 ◽  
Author(s):  
Yanran Wang ◽  
Zhaohui Jin ◽  
Zhijun Wang ◽  
Xuehua Jiang ◽  
Ling Wang
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Phase I ◽  
Phase I Study ◽  
Multiple Dose ◽  
Open Label ◽  
Parallel Group ◽  
Pharmacokinetic Properties ◽  
Dose Oral

scholarly journals Effect of renal function on the pharmacokinetics of fimasartan: a single-dose, open-label, Phase I study

2014 ◽  
pp. 1723 ◽  
Author(s):  
Seokuee Kim ◽  
Jongtae Lee ◽  
Donghoon Shin ◽  
Kyoung Soo Lim ◽  
Yon Su Kim ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Phase I ◽  
Phase I Study ◽  
Open Label ◽  
Open Label Phase

scholarly journals Phase I study of omeprazole - Single-dose and multiple-dose studies.

1988 ◽  
Vol 19 (4) ◽  
pp. 667-679 ◽  
Author(s):  
Mitsuyoshi NAKASHIMA ◽  
Mitsutaka KANAMARU ◽  
Hisakuni HASHIMOTO ◽  
Yoshiharu TAKIGUCHI ◽  
Atsuhiro MIZUNO ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Phase I Study ◽  
Multiple Dose

scholarly journals Single-Dose Phase I Study To Evaluate the Pharmacokinetics of Posaconazole in New Tablet and Capsule Formulations Relative to Oral Suspension

2012 ◽  
Vol 56 (8) ◽  
pp. 4196-4201 ◽  
Author(s):  
Gopal Krishna ◽  
Lei Ma ◽  
Monika Martinho ◽  
Edward O'Mara
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Coefficient Of Variation ◽  
Phase I Study ◽  
Area Under The Curve ◽  
Oral Suspension ◽  
High Fat ◽  
Open Label ◽  
Proven Efficacy ◽  
Fat Meal

ABSTRACTPosaconazole oral suspension, a marketed extended-spectrum triazole with proven efficacy as antifungal treatment and prophylaxis, should be taken with food to maximize absorption. New tablet and capsule formulations have been developed in an attempt to optimize absorption and bioavailability. The aims of this exploratory open-label, partially randomized, 2-part, 4-way, single-dose crossover study in 16 healthy adults were to characterize pharmacokinetics for posaconazole tablet and capsule formulations relative to those for posaconazole oral suspension under fasted and fed conditions and to assess safety and tolerability. Under fasted conditions, posaconazole exposures (area under the curve [AUC]) for the tablet and capsule formulations were similar (mean AUC from time zero to infinity [AUC0–∞], tablet A, 11,700 ng · h/ml [coefficient of variation {CV}, 26%]; tablet B, 11,300 ng · h/ml [CV, 22%]; capsule, 11,000 ng · h/ml [CV, 25%]) and were substantially higher than the exposure for the oral suspension (mean AUC0–∞, 3,420 ng · h/ml [CV, 44%]). Tablets and capsule showed less variability in exposure than the oral suspension. In fed subjects, tablets and capsule resulted in similar AUC values (mean AUC0–∞, tablet A, 11,900 ng · h/ml [23%]; tablet B, 12,400 ng · h/ml [CV, 25%]; capsule, 12,300 ng · h/ml [CV, 28%]) and slightly higher exposure than the oral suspension (mean AUC0–∞, 8,750 [CV, 24%]). Median times to the maximum concentration of drug in plasma were 4 to 5 h (fasted conditions) and 6 to 8 h (fed conditions). Mean half-lives values were similar for all formulations under fed and fasted conditions (23.1 to 29.2 h). Consistent with previous data, exposure for the oral suspension increased 2.5- to 3-fold when it was given with a high-fat meal. Conversely, exposures for tablets and capsule were not markedly affected by food. All formulations of posaconazole at 100 mg were safe and well tolerated.

scholarly journals Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study

2012 ◽  
pp. 407
Author(s):  
Lieve Vandeplassche ◽  
Smith ◽  
Mannaert ◽  
Verhaeghe ◽  
Kerstens ◽  
...  
Keyword(s):  
Single Dose ◽  
Renal Impairment ◽  
Phase I ◽  
Phase I Study ◽  
Open Label ◽  
Open Label Phase

Pharmacokinetic Properties of Ketanserin in Man with Normal or Reduced Renal Function after Single Dose Oral Administration

Drugs ◽  
1988 ◽  
Vol 36 (Supplement 1) ◽  
pp. 114
Author(s):  
K. Onoyama ◽  
N. Ouchi ◽  
T. Ando ◽  
M. Fujishima ◽  
Y. Uji ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Oral Administration ◽  
Pharmacokinetic Properties ◽  
Dose Oral ◽  
Reduced Renal Function
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