At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
selumetinib 75mg single dose +2 moredrug
Likely dose
selumetinib 75mg single dosefrom 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 Phase I, Single Centre, Randomised, Open Label, Crossover Study to Assess the Bioequivalence or Relative Bioavailability of Variants of Selumetinib (AZD6244, Hyd-Sulfate) Blue Capsules in Healthy Male Volunteers Aged 18 to 45 Years
In Brief
A Phase 1 clinical trial evaluating selumetinib 75mg single dose for Healthy Volunteers Bioequivalence or Bioavailability Study. Completed, enrolled 48 participants across 1 site.
Detailed Summary
A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male Volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartFeb 2015
Primary CompletionApr 2015
TodayJul 2026
First PostedDec 23, 2014
Enrollment StartFeb 1, 2015
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.5 years ago
Interventions
selumetinib 75mg single dosedrug
3 blue capsules of 25 mg given as a single dose
selumetinib 75mg single dosedrug
3 capsules of 25 mg given as a single dose
selumetinib 75mg single dosedrug
3 capsules of 25 mg given as a single dose