37
Participants
Start Date
April 21, 2007
Primary Completion Date
November 26, 2007
Study Completion Date
November 26, 2007
Formulation A
Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation B
Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation C
Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation D
Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
GSK Investigational Site, Berlin
GSK Investigational Site, Prague
GSK Investigational Site, Grodzisk Mazowiecki
GSK Investigational Site, Poznan
Lead Sponsor
GlaxoSmithKline
INDUSTRY