Open‐Label, Randomized, Single‐Dose, 2‐Period, 2‐Sequence Crossover, Comparative Pharmacokinetic Study to Evaluate Bioequivalence of 2 Oral Formulations of Olanzapine Under Fasting and Fed Conditions

2019 ◽  
Vol 9 (5) ◽  
pp. 621-628
Author(s):  
Ping Du ◽  
Pengfei Li ◽  
Hongchuan Liu ◽  
Rui Zhao ◽  
Zhixia Zhao ◽  
...  
Keyword(s):  
Single Dose ◽  
Pharmacokinetic Study ◽  
Open Label ◽  
Comparative Pharmacokinetic ◽  
Oral Formulations ◽  
Period 2

scholarly journals Comparative Pharmacokinetic Study Among 3 Metformin Formulations in Healthy Mexican Volunteers: A Single-Dose, Randomized, Open-Label, 3-Period Crossover Study

2015 ◽  
Vol 77 ◽  
pp. 18-23 ◽  
Author(s):  
Sandra Lucía Montoya-Eguía ◽  
Lourdes Garza-Ocañas ◽  
Christian Tadeo Badillo-Castañeda ◽  
Eduardo Tamez-de la O ◽  
Teresa Zanatta-Calderón ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Pharmacokinetic Study ◽  
Open Label ◽  
Comparative Pharmacokinetic

Bioavailability of Two Single-Dose Oral Formulations of Omeprazole 20 mg: An Open-Label, Randomized Sequence, Two-Period Crossover Comparison in Healthy Mexican Adult Volunteers

2008 ◽  
Vol 30 (4) ◽  
pp. 693-699 ◽  
Author(s):  
Jorge Luis Poo ◽  
Juan Francisco Galán ◽  
Alejandra Rosete ◽  
Alberto de Lago ◽  
Iván Oliva ◽  
...  
Keyword(s):  
Single Dose ◽  
Open Label ◽  
Oral Formulations ◽  
Dose Oral ◽  
Adult Volunteers ◽  
Crossover Comparison

scholarly journals The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Chuleegone Sornsuvit ◽  
Darunee Hongwiset ◽  
Songwut Yotsawimonwat ◽  
Manatchaya Toonkum ◽  
Satawat Thongsawat ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Pharmacokinetic Study ◽  
Oral Bioavailability ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Blood Samples ◽  
Rapid Absorption ◽  
The Mean

The present study aimed to determine the pharmacokinetic parameters and bioavailability of silymarin 140 mg SMEDDS formulation. An open-label, single-dose pharmacokinetic study was conducted. Twelve healthy volunteers were included in the study. After the volunteers had fasted overnight for 10 h, a single-dose generic silymarin 140 mg SMEDDS soft capsule was administered. Then 10 ml blood samples were taken at 0.0, 0.25, 0.50, 0.75, 1.0, 1.33, 1.67, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 h. The plasma silybin concentrations were analyzed using validated LC-MS/MS. The pharmacokinetic parameters were analyzed and calculated. The pharmacokinetic parameters were calculated after silymarin had been administered as a single capsule. The mean (range) Cmax was 812.43 (259.47–1505.47) ng/ml at 0.80 (0.25–1.67) h (tmax). The mean (range) AUC0-t and AUC0-inf were 658.80 (268.29–1045.01) ng.h/ml and 676.98 (274.10–1050.96) ng.h/ml, respectively. The mean ke and t1/2 were 0.5386 h-1 and 1.91 h, respectively. The silymarin SMEDDS formulation soft capsule showed rapid absorption and high oral bioavailability.

scholarly journals An Open-Label, Single-Dose, Crossover Study of the Pharmacokinetics and Metabolism of Two Oral Formulations of 1-Octanol in Patients with Essential Tremor

2011 ◽  
Vol 8 (4) ◽  
pp. 753-762 ◽  
Author(s):  
Fatta B. Nahab ◽  
Loretta Wittevrongel ◽  
Dominic Ippolito ◽  
Camilo Toro ◽  
George J Grimes ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Essential Tremor ◽  
Open Label ◽  
Oral Formulations

Comparative bioavailability of curcuminoids from a water-dispersible high curcuminoid turmeric extract against a generic turmeric extract: a randomized, cross-over, comparative, pharmacokinetic study

2021 ◽  
Author(s):  
Shefali Thanawala ◽  
Rajat Shah ◽  
KrishnaRaju Venkata Alluri ◽  
Venkateswarlu Somepalli ◽  
Sanjay Vaze ◽  
...  
Keyword(s):  
Pharmacokinetic Study ◽  
Peak Plasma ◽  
Curcuma Longa ◽  
Dose Ratio ◽  
Open Label ◽  
Comparative Pharmacokinetic ◽  
Water Dispersible ◽  
Turmeric Extract ◽  
Comparative Bioavailability ◽  
To Receive

Abstract Objectives The therapeutic utility of turmeric (Curcuma longa L., Zingiberaceae) is limited due to low bioavailability of its active principal curcuminoids. This study evaluates the pharmacokinetic characteristics of a natural, water-dispersible turmeric extract containing 60% curcuminoids (TurmXtra 60N), referred to as WDTE60N, compared to standard turmeric extract 95% (STE95). Methods This open-label, two-way crossover, single oral dose, comparative pharmacokinetic study, randomized 14 subjects to receive one capsule of WDTE60N (150 mg curcuminoids) or three capsules of STE95 (500 mg curcuminoids each). The resulting dose ratio of actives for WDTE60N:STE95 was 1:10. Key findings Peak plasma levels of free curcumin, total curcuminoids, tetrahydrocurcumin and demethoxycurcumin were similar (P > 0.05). Cmax of total curcumin was higher (P = 0.0253) for WDTE60N at a 10-fold lower dose compared to STE95 (43.5 ± 28.5 vs. 21.3 ± 10.7 ng/ml). Mean AUC0-t was higher (P < 0.001) for free curcumin and comparable for total curcumin and total curcuminoids with WDTE60N than with STE95. Five adverse events were reported in three subjects (mild in severity) and were unrelated to study products. Conclusion WDTE60N showed higher absorption and comparable exposure for free curcumin, total curcumin and total curcuminoids at a 10-fold lower dose than STE95.

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