Enhancing effect of borneol on pharmacokinetics of ginsenoside Rb 1 , ginsenoside Rg 1 and notoginsenoside R 1 in healthy volunteers after oral administration of compound Danshen dropping pills (CDDP)

2022 ◽  
Author(s):  
Dayong Zheng ◽  
Yang Chu ◽  
Shuming Li ◽  
Shuiping Zhou ◽  
Wei Li ◽  
...  
Keyword(s):  
Oral Administration ◽  
Healthy Volunteers ◽  
Enhancing Effect

Bioequivalence of Two Tablet Formulations of Atenolol after Single Oral Administration in Healthy Volunteers

2011 ◽  
Vol 50 (03) ◽  
pp. 243-247
Author(s):  
Ioannis Niopas ◽  
Athanasios Daftsios ◽  
Ioannis Xanthakis ◽  
Nicolaos Nikolaidis ◽  
Samuel Njau
Keyword(s):  
Oral Administration ◽  
Healthy Volunteers ◽  
Single Oral Administration ◽  
Tablet Formulations

Abstract 1696: Compound RVX-208 Modulates HDL-C Levels and Function in Non-human Primates and in Early (phase I) Human Trials

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Larbi Krimbou ◽  
Ravi Jahagirdar ◽  
Dana Bailey ◽  
Anouar Hafiane ◽  
Isabelle Ruel ◽  
...  
Keyword(s):  
Oral Administration ◽  
Healthy Volunteers ◽  
Size Distribution ◽  
Cholesterol Efflux ◽  
Oral Absorption ◽  
Therapeutic Potential ◽  
Human Study ◽  
Treated Group ◽  
Atherosclerotic Cardiovascular Disease ◽  
Hdl Function

The novel compound RVX-208 is a small molecule that upregulates the gene expression of apoA-I and raises HDL-C in non-human primates. Here, we examined the effects of oral administration of RVX-208 on serum apoA-I and HDL-C levels , HDL size distribution, and HDL function. African green monkeys received RVX-208 (7.5, 15 and 30 mg/kg; twice daily and 60 mg/kg; once daily) or vehicle control for 28, 42, and 63 days. We report that RVX-208 chronic treatment resulted in a highly significant increase in the average of serum apoA-I and HDL-C levels (57% and 92%, respectively). Interestingly, RVX-208 treatment modified the distribution of HDL particle size causing a significant increase in preβ1-LpA-I and larger α1-LpA-I species. The ability of serum to promote cholesterol efflux via ABCA1, ABCG1 or SR-BI-dependent pathways in a cell culture model was significantly increased by RVX-208. The phase Ia safety and pharmacokinetic human study comprised of a total of 80 subjects. In the multiple ascending dose arm, 24 participants were randomly assigned to 3 cohorts of 8 healthy volunteers (6 active and 2 placebo), and received oral administration of RVX-208 at 2, 3 and 8 mg/kg per day or placebo for 7 days. The compound was well tolerated and had good oral absorption meeting the objectives of safety and pharmacokinetics. ApoA-I, HDL-C, HDL size distribution and ABCA1-dependent cholesterol efflux were assessed at days 1 (predose) and 7. The percent change from baseline to day 7 for apoA-I was 11% higher (P = 0.03) in the RVX-208 treated participants compared to placebo. Interestingly, preβ1-LpA-I change was 30% (P = 0.02) higher in the actively treated group and was found to strongly correlate with increased apoA-I levels (R2 = 0.72). Furthermore, ABCA1-dependent cholesterol efflux change was 10% higher (P = 0.03) and was found to correlate with increased preβ1-LpA-I . Taken together, these pharmacodynamic data from human healthy volunteers show consistent trends in apoA-I production and HDL functionality, supporting the findings in the African green monkey. Further investigation of the effect of RVX-208 on the HDL metabolic pathway is ongoing in humans and animals to establish the mechanisms of action and therapeutic potential in treating atherosclerotic cardiovascular disease.

Evaluation of the Bio equivalence and Pharmacokinetics of Two Lisinopril Tablet Formulations after Single Oral Administration in Healthy Volunteers

2011 ◽  
Vol 54 (01) ◽  
pp. 15-19
Author(s):  
Manolis Georgarakis ◽  
Andreas Tsakalof ◽  
Fotini Zougrou ◽  
Georgios Kontopoulos ◽  
Iakovos Tsiptsios
Keyword(s):  
Oral Administration ◽  
Healthy Volunteers ◽  
Single Oral Administration ◽  
Tablet Formulations
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