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Fig 1.

Study design.

Schematic representation of the study design. A single dose of rupatadine was given on Day 1 and multiple ascending doses were administered on days 2–5.

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Fig 2.

CONSORT 2010 Flow Diagram.

Outlined design of the clinical study.

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Table 1.

Demographic characteristics of treatment groups.

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Table 1 Expand

Fig 3.

Mean (±SD) plasma concentration.

Profiles of rupatadine over time (A), UR-12790 (desloratadine) (B) and UR-12788 (3-hydroxydesloratadine) (C) following administration of single and multiple doses of rupatadine (10, 20 and 40 mg) on Days 1 and 5.

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Table 2.

Mean pharmacokinetic (±SD) parameters following administration of single doses of rupatadine (10, 20 and 40 mg).

Median (min–max) values are presented for tmax.

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Table 2 Expand

Table 3.

Mean pharmacokinetic (±SD) parameters following administration of multiple doses of rupatadine (10, 20 and 40 mg).

Median (min–max) values are presented for tmax.

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Table 3 Expand

Fig 4.

Cognitive function tests.

Tests were performed at 1 (tmax) and 3 h after administration of placebo, 10, 20 and 40 mg of rupatadine (increasing doses from left to right with dark grey representing placebo and lighter grey tones indicate increasing doses) on Day 1 (D1) and Day 5 (D5). A) Rapid Visual Information Processing (sum correct all conditions) test (range– 0–144 msec); B) RT benefit congruent (range -800 +800); C) RT cost incongruent (range -800 +800); D) Spatial Working memory (range 0–1280 pixel); E) Reaction Time (range 200–3000); F) Visual Analogue Scales (range 1–100 percentage). Median values of change from time matched baseline are presented. Individual values are given in addition to the median and represented by white circles.

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