At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 enrolled
Drug / intervention
Granisetron hydrochloride 1 mg tablets +1 moredrug
Likely dose
Granisetron hydrochloride 1 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Granisetron hydrochloride 1 mg tablets and Kytril® 1 mg tablets for Healthy. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
Primary CompletionJul 2005
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Granisetron hydrochloride 1 mg tabletsdrug
2 x 1 mg, single dose non-fasting
Kytril® 1 mg tabletsdrug
2 x 1 mg, single dose non-fasting