Pharmacokinetics of Lamivudine, Zidovudine, and Nevirapine Administered as a Fixed-Dose Combination Formulation Versus Coadministration of the Individual Products

2007 ◽  
Vol 47 (11) ◽  
pp. 1381-1389 ◽  
Author(s):  
J. F. Marier ◽  
M. DiMarco ◽  
R. Guilbaud ◽  
C. Dodard ◽  
G. Morelli ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination ◽  
The Individual ◽  
Combination Formulation

Pharmacokinetics of fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and efavirenz: results of a randomized, crossover, bioequivalence study

2016 ◽  
Vol 28 (5) ◽  
pp. 491-498 ◽  
Author(s):  
Dhiraj Abhyankar ◽  
Ashish Shedage ◽  
Milind Gole ◽  
Preeti Raut
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Geometric Mean ◽  
Bioequivalence Study ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Geometric Mean Ratio ◽  
Open Label ◽  
Post Dose ◽  
Dose Combination ◽  
The Individual

The objective of this study was to assess the bioequivalence between a fixed-dose combination of tenofovir disoproxil fumarate/lamivudine/efavirenz 300/300/600 mg and the individual innovator products. A randomized, balanced, open-label, two-sequence, two-treatment, two-period, single dose, crossover study in 48 healthy adults was conducted. Dosing was separated by a washout period of 32 days. Twenty-seven blood samples were collected in each period from pre-dose to 72 h post-dose. The data of 45 subjects were analyzed for pharmacokinetics and safety. Ninety percent CIs of geometric mean ratio on Cmax, AUC0–t, and AUC0-inf for tenofovir and lamivudine and on Cmax and AUC0-72 for efavirenz were within the acceptance criteria (80–125%). For tenofovir disoproxil fumarate, the Tmax, Kel, and t1/2 values for the test and reference products were 1.02 versus 0.91 h, 0.04 versus 0.04/h, 18.67 versus 18.46 h, respectively. For lamivudine, the Tmax, Kel, and t1/2 values were: 1.38 versus 1.30 h, 0.21 versus 0.19/h, 3.44 versus 3.91 h, respectively. For efavirenz, the Tmax values for the test and reference products were 3.71 and 3.65 h, respectively. Both the treatments were well tolerated. Our findings suggest that the tested formulation is bioequivalent to the innovators’ formulations, and both treatments were well tolerated.

Efficacy and safety of aclidinium/formoterol fixed-dose combination in patients with COPD, stratified by ICS use

Pneumologie ◽  
2016 ◽  
Vol 70 (S 01) ◽  
Author(s):  
ED Bateman ◽  
K Chapman ◽  
S Rennard ◽  
L Rekeda ◽  
M Moya ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Dose Combination

135-OR: The Effect of Fixed-Dose Combination of Insulin Degludec and Liraglutide on Serum Lipoprotein Metabolism in Patients with Type 2 Diabetes Mellitus

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 135-OR
Author(s):  
ELENI PAPPA ◽  
CHRISTINA KOSTARA ◽  
CONSTANTINOS TELLIS ◽  
ALEXANDROS D. TSELEPIS ◽  
ELENI BAIRAKTARI ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Lipoprotein Metabolism ◽  
Serum Lipoprotein ◽  
Insulin Degludec ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination
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