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A Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection

To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.
PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.

开始日期-

申办/合作机构

Hoechst Marion Roussel

NCT00002150

/ Completed临床2期

A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

开始日期-

申办/合作机构

Hoechst Marion Roussel

NCT00002151

/ Completed临床2期

A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

开始日期-

申办/合作机构

Hoechst Marion Roussel

100 项与 Hoechst Marion Roussel 相关的临床结果

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0 项与 Hoechst Marion Roussel 相关的专利（医药）

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项与 Hoechst Marion Roussel 相关的文献（医药）

1996-09-01·European Journal of Drug Metabolism and Pharmacokinetics4区 · 医学

The effect of food on the relative bioavailability of deflazacort

4区 · 医学

Article

作者: Rao, Niranjan ; Weir, S. ; Ellert, M. ; Arumugham, T.

The effect of high- and low-fat meals on the relative bioavailability of deflazacort tablets was investigated in 12 healthy, adult males who were administered 36 mg deflazacort under fasted and fed conditions in a crossover fashion. Serial plasma samples were drawn up to 24 h post-dose and quantified for the active metabolite 21-desacetyl deflazacort (DFZ 21-OH) by a rapid and sensitive HPLC method. Following deflazacort administration with high-fat and low-fat meals and under fasted conditions, DFZ 21-OH area under the curve to infinity averaged 508.39 +/- 131.70, 510.05 +/- 148.30 and 511.90 +/- 188.16 ng.h/ml. DFZ 21-OH Cmax averaged 156.31 +/- 33.31, 156.85 +/- 40.17 and 188.05 +/- 53.35 ng/ml for high-fat, low-fat and fasted treatments, respectively. Differences in Cmax between the fed versus fasted treatments were statistically significant (P < 0.05). The decrease in Cmax under fed conditions was accompanied by an increase in mean Tmax of approximately 17-85% compared to fasted conditions. As expected, terminal half-life was not affected. These data indicate that co-administration of deflazacort tablets with high-fat and low-fat meals leads to a small decrease in rate but does not affect its extent of absorption.

100 项与 Hoechst Marion Roussel 相关的药物交易

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100 项与 Hoechst Marion Roussel 相关的转化医学

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