A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers.

This is a randomized, double-blind, single-dose, parallel group phase 1 study to assess pharmacokinetic similarity, safety, and tolerability of BS-503a, a proposed bevacizumab biosimilar. A total of 114 male healthy subjects were randomized (1:1) to receive a single 3 mg/kg intravenous dose of either BS-503a or bevacizumab (Avastin). Pharmacokinetic (PK) blood samples were collected up to Day 78, and serum drug concentrations were measured using a validated enzyme-linked immunosorbent assay.

Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen or ibuprofen acid incorporating poloxamer in healthy volunteers.

Background: The aim of this study was to compare the pharmacokinetic properties of sodium ibuprofen and ibuprofen acid incorporating poloxamer with standard ibuprofen acid tablets.

Methods: Twenty-two healthy volunteers were enrolled into this randomised, single-dose, 3-way crossover, open-label, single-centre, pharmacokinetic study. After 14 hours' fasting, participants received a single dose of 2x200 mg ibuprofen acid tablets (standard ibuprofen), 2x256 mg ibuprofen sodium dihydrate tablets (sodium ibuprofen; each equivalent to 200 mg ibuprofen acid) and 2x200 mg ibuprofen acid incorporating 60 mg poloxamer 407 (ibuprofen/poloxamer).

Control of asthma in Canada: failure to achieve guideline targets.

Objective: To assess the degree of asthma control achieved by patients with asthma in Canada and to describe the impact of poor asthma control.

Design: Population-based, cross-sectional telephone interview survey of Canadians with doctor-diagnosed asthma.

Subjects And Methods: Random digit dialing was used to identify a representative sample of Canadians with asthma.

At the coalface, but on the receiving end.

In dealing with patients the doctor is very often paternalistic. No more so than when the patient is unable to help him--or herself. Modern technology allows people to be kept alive in "intensive care" where they often become an "object" at the centre of proceedings.

Absence of a sertraline-mediated effect on the pharmacokinetics and pharmacodynamics of carbamazepine.

Unlabelled: A double-blind, randomized, placebo-controlled study was conducted in 14 healthy male volunteers to assess the effects of sertraline on the pharmacokinetics and pharmacodynamics of carbamazepine.

Method: Subjects received carbamazepine 200 mg once daily for 2 days and every 12 hours thereafter. On Days 16 to 32, subjects also received either sertraline or placebo daily.

Absence of a sertraline-mediated effect on digoxin pharmacokinetics and electrocardiographic findings.

Unlabelled: The effects of oral administration of sertraline on the plasma concentration profile and renal clearance of digoxin were assessed in 20 healthy male subjects in a double-blind, randomized study.

Method: All subjects first received digoxin 0.5 mg twice daily on Day 1, 0.

Effect of tenidap sodium on digoxin pharmacokinetics in healthy young men.

1. The effects of tenidap sodium and placebo on digoxin pharmacokinetics were compared in 14 healthy young men, in a double-blind, parallel-group study lasting for 24 days. 2.

AICA-riboside: safety, tolerance, and pharmacokinetics of a novel adenosine-regulating agent.

AICA-riboside (5-amino-4-imidazole carboxamide ribonucleoside) is a novel adenosine-regulating agent that is currently being investigated for the treatment of ischemic heart disease. In a placebo-controlled, double-blind study in healthy men, we evaluated the safety and kinetics of the drug after oral and IV administration of 10, 25, 50, and 100 mg/kg doses. At each dose level, four subjects received active drug and two subjects received placebo with a 1-week wash-out period between the IV and oral doses.

Pharmacokinetics of cilazapril during repeated oral dosing in healthy young volunteers.

The pharmacokinetics of cilazapril and its active metabolite cilazaprilat in plasma were investigated in an open study of 13 healthy male volunteers, aged 18 to 43 years. One capsule containing 2.5 mg cilazapril was administered to each volunteer daily for 8 days.

Urinary recovery and tolerability of FCE 22101 following single intravenous administration under restricted and high fluid intake.

The urinary recovery and tolerability of FCE 22101, a broad spectrum injectable penem, were investigated in a multicentre single-blind randomized crossover study of 60 healthy male volunteers. Single 1 g doses of FCE 22101 or placebo were given by intravenous bolus at weekly intervals. FCE 22101 was given either after intake of 750 ml water (treatment A) or after 8 h of water restriction (treatment B).

The effects of cicletanine, a new antihypertensive compound, on the flare and weal response to histamine.

This was an open experimental pilot study in five volunteers to identify any useful effect of cicletanine in the prevention or relief of the flare and weal response to histamine injection on the forearm. Areas of the flare and weal responses to three different concentrations of intradermal histamine injection were determined. Choice reaction time was measured to assess CNS performance.

Long-term monitoring of the effects of thymoxamine hydrochloride tablets in the management of patients with Raynaud's disease.

Seventeen patients with Raynaud's disease were followed whilst receiving treatment with 40 mg thymoxamine hydrochloride 4-times daily for period ranging between 11 and 19 months. Digital artery patency and blood flow changes, assessed by Doppler ultrasound techniques after different thermal stresses, were monitored regularly as were platelet aggregation to ADP and collagen, platelet adhesion to glass beads, measures of blood coagulation and fibrinolysis, and plasma viscosity. Significant clinical improvement noted at 1 month appeared to improve further at 3 months and was maintained thereafter.