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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00411866 |
The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: SB773812 Drug: Ketoconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg. |
Estimated Enrollment: | 36 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NAA105416 |
Study First Received: | December 13, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00411866 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
pharmacokinetics, safety |
Clotrimazole Miconazole Tioconazole Healthy Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |