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Effect of Age and Gender on the Safety, Tolerability, and Pharmacokinetics of BAY 12–9566 in Healthy Subjects
Author(s) -
Lathia Chetan,
Shah Anita,
Sundaresan Pavur
Publication year - 2001
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700122010672
Subject(s) - tolerability , pharmacokinetics , bay , medicine , placebo , volume of distribution , adverse effect , plasma concentration , physiology , civil engineering , alternative medicine , pathology , engineering
The impact of age and gender on the single‐dose pharmacokinetics, safety, and tolerability of BAY 12–9566 was evaluated in healthy subjects. Volunteers were grouped according to age and gender (13 young males, 11 elderly males, and 12 elderly females) and then randomized in a 2:1 ratio to receive a single oral 50 mg dose of BAY 12–9566 or placebo. Serial plasma samples were collected up to 336 hours post dose and assayed for BAY 12–9566. Peak plasma concentration, time to reach peak plasma concentration, the area under the concentration‐time curve, oral clearance, volume of distribution, and elimination half‐life were calculated. BAY 12–9566 was well tolerated in all treatment groups, and no serious adverse events occurred during the study. Substantial age‐ or gender‐related differences were not observed for any of the pharmacokinetic parameters tested. Based on these pharmacokinetic and tolerability profiles, age‐ or gender‐related dose adjustments were not required for BAY 12–9566.