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Biomedical subjects

E Novak

Publications and source records attributed to E Novak.

At least 37 records · Page 2Linked to original sources
PubMed1986

Pharmacokinetics and dose proportionality of cefpimizole in normal humans after intramuscular administration.

The pharmacokinetics of cefpimizole (free acid equivalents of cefpimizole sodium), a broad-spectrum cephalosporin antibiotic, were evaluated after intramuscular administration of single doses (dose range, 100 to 1,000 mg) and multiple doses (dose range, 500 to 2,000 mg) given b.i.d. for 6 or 11 days. The kinetics after intramuscular administration correspond to a one-compartment model with first-order input. The apparent volume of distribution of the absorbed dose averaged 18.6 +/- 3.4 (standard deviation) liters for 58 individuals; the absorption-phase and elimination-phase rate constants averaged 2.53 +/- 1.16 h-1 (half-life, 0.27 h) and 0.338 +/- 0.041 h-1 (half-life, 2.05 h), respectively; and the mean residence time was 3.43 +/- 0.43 h. The total body clearance of the absorbed dose after single-dose intramuscular administration was 102 +/- 13 ml/min. The primary route of elimination was renal with 73 to 83% of the administered dose excreted in the urine as unchanged drug. Renal clearance averaged 81 +/- 13 ml/min. Dose proportionality was obtained from area under the plasma curve, concentration maximum in plasma, and cumulative urinary excretion levels. Multiple-dose evaluation of intramuscular administration of cefpimizole indicated no apparent change in the absorption or elimination phases after b.i.d. dosing for 6 or 11 days. The kinetic parameters determined from multiple-dose plasma and urine levels were in close agreement with the same parameters calculated from single-dose results. No apparent accumulation of cefpimizole occurred, and nondetectable levels of drug were observed in the 24-h plasma and 24- to 48-h urine specimen after administration of the last dose. The kinetics of cefpimizole after intramuscular administration were similar to the kinetics obtained after intravenous infusion.

Adult↗
PubMed1985

Amorphic lenses: a mobility aid for patients with retinitis pigmentosa.

An amorphic lens, designed by William Feinbloom, was tested on 69 patients with retinitis pigmentosa. The results showed that one-half of the patients experienced immediate improvement in mobility and one-third of the patients fitted with the amorphic lens reported (after wearing the lenses for 2 weeks) improved mobility compared to their mobility before using the lens.

Equipment Design↗
PubMed1984

Minoxidil stimulates cutaneous blood flow in human balding scalps: pharmacodynamics measured by laser Doppler velocimetry and photopulse plethysmography.

In a double-blind study with randomly assigned topical solutions of 0%, 1%, 3%, or 5% minoxidil, the blood flow in balding scalps of 16 human volunteers was measured by the noninvasive techniques of both laser Doppler velocimetry (LDV) and photopulse plethysmography (PPG). On two consecutive days, an 0.25-ml volume of the assigned minoxidil formulation was spread uniformly over a 100-cm2 area of each side of the bald scalp and cutaneous blood flow was recorded for the following 4 h. Both measurement techniques showed that the 5% minoxidil solution stimulated the microcirculation of the bald scalp. Increased blood flow was greater with the 5% minoxidil solution than with the other treatments. Measured by LDV on day 1, the increase (p less than 0.0001) in blood flow occurred within 15 min of application of the 5% solution of minoxidil and was maintained at least through hour 1. On day 2, LDV showed blood flow stimulation with the 5% solution was 3-fold (p less than 0.0001) within 15 min of application and was so maintained for about 1 h. Measured by PPG, the only statistically significant (p less than 0.01) response occurred with the day 2 application of the 5% minoxidil solution. PPG is dependent on local blood volume and is only weakly correlated to cutaneous blood flow, which makes it unsuitable for this kind of study. Analysis of vital signs for days 1 and 2 revealed no systemic effect from treatment with minoxidil, suggesting that the blood flow stimulation was directly related to the topical application of minoxidil.

Administration, Topical↗
PubMed1984

Inflammatory response to sodium lauryl sulfate in aqueous solutions applied to the skin of normal human volunteers.

In this double-blind study, the intensity and duration of the inflammatory response induced by various concentrations of sodium lauryl sulfate (SLS) solution on the forearms of 36 normal male volunteers was dependent upon the concentration and number of applications of SLS. One 24-h application of the 4% or 5% aqueous SLS solution or two successive 24-h applications of the 2% or 3% SLS solutions were sufficient to cause an inflammatory response in the epidermis. Such response makes the skin more permeable for the testing of topical formulations of compounds to document their propensity to irritate.

Adolescent↗
PubMed1983

Adrenal suppression with high-potency corticosteroid ointment formulations in normal subjects.

In this 14-day, double-blind, in-clinic study, 24 healthy male volunteers were assigned at random to one of four treatment groups to compare the effects of a new formulation of 0.05% diflorasone diacetate ointment in a vehicle of propylene glycol (PG) with the effects of ointments of 0.05% fluocinonide, 0.05% clobetasol propionate, or the vehicle for diflorasone diacetate PG. The medication was applied to 75% of each subject's total body surface once a day for six consecutive days. During treatment and four days before and four days after treatment, various indicators of adrenal suppression were measured. A reduction in plasma cortisol levels was seen in several patients in each treatment group during the pretreatment period (days 1-4). Plasma cortisol continued to decrease during treatment and tended to return to pretreatment levels after cessation of therapy. There were no statistically significant differences between treatment groups. The lowering of plasma cortisol values in all groups was attributed to the applied medications as well as to the volunteers' change in daily routine and environment.

Adult↗
PubMed1980

Fixed eruption and fever after urography.

We have described a patient with fixed bullous eruption, usually associated with severe fever, occurring on five occasions after a series of seven intravenous urograms between 1974 and 1979. Diagnosis was initially obscured because the onset of fever and dermatitis was delayed as long as 72 hours. This is only the second report of true ioderma ascribed to urographic contrast media.

Fever↗
PubMed1980

Endogenous serum testosterone in males after different doses and routes of administration of medroxyprogesterone acetate.

The effects of different doses and routes of administration (oral and IM) of medroxyprogesterone acetate on endogenous testosterone secretion were studied in healthy male volunteers. There were three treatment groups. Serum testosterone levels, measured by radioimmunoassay before, during and after different doses of medroxyprogesterone acetate, were significantly lowered (p < 0.05) in these subjects. A tendency to return toward pretreatment values was noted within three to six weeks after the last dose of medroxyprogesterone acetate. The IM route of administration suppressed the testosterone levels for the longest period of time. No indication of drug-induced toxicity, as judged by vital signs, systemic side effects, standard laboratory evaluations and some special clinical evaluations, was found during treatment or in the period immediately following the course of therapy. No serious or untoward side effects were encountered.

Administration, Oral↗
PubMed1976

Unfavorable effect of atropine-diphenoxylate (Lomotil) therapy in lincomycin-caused diarrhea.

In this double-blind, randomized study, 200 normal subjects received a three-day course of one of five treatment regimens: lincomycin hydrochloride monohydrate injection (sterile solution, 300 mg/ml) with two tablets of either placebo, a mixture of atropine sulfate and diphenoxylate hydrochloride (Lomotil), an aspirin-phenacetin-caffeine (APC) combination or the latter with codeine, or an injection of saline with two placebo tablets. Gastrointestinal irritation was most prominent in subjects receiving lincomycin with atropine-diphenoxylate and lincomycin with APC plus codeine (P less than .05). Decreased intestinal motility from atropine-diphenoxylate or codeine may increase the contact time between the lincomycin (or its metabolites) or some developing toxic substances and the mucosal epithelium. The use of atropine-diphenoxylate or codeine in treating lincomycin-induced diarrhea may be questionable.

Administration, Oral↗
PubMed1976

Anorectal pruritus after intravenous hydrocortisone sodium succinate and sodium phosphate.

A double-blind study demonstrated that single intravenous doses of 100, 200, or 400 mg of hydrocortisone sodium succinate and hydrocortisone sodium phosphate were similar in eosinophil suppression, elevation of glucose, white blood count differential shifts (polymorphonuclear cells, lymphocytes, and monocytes), and urinary excretion of sodium and potassium but not in incidence of side effects. More subjects receiving hydrocortisone sodium phosphate experienced systemic or localized adverse effects than those receiving hydrocortisone sodium succinate. The most common side effect was burning or itching in the anorectal area, which occurred in 16 of 18 subjects medicated with hydrocortisone sodium phosphate, in 1 subject of 6 treated with placebo (saline), and in none who received the sodium succinate. The effect is attributed to the phosphate steroid and appears to last as long as it takes to convert to cortisol.

Adult↗