Conditions: Healthy Volunteers Bioequivalence or Bioavailability Study
Keywords: bioequivalence bioavailability pharmacokinetics Phase I AZD6244 cancer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: AZD6244 blue reference capsules (3 x 25 mg) administered orally arm 2: AZD6244 blue capsules (3 x 25 mg) Variant 1 (free base variant) administered orally arm 3: AZD6244 blue capsules (3 x 25 mg) Variant 2 (vitamin E polyethylene glycol succinate \[TPGS\] variant) administered orally

Interventions: intervention 1: selumetinib 75mg single dose intervention 2: selumetinib 75mg single dose intervention 3: selumetinib 75mg single dose
Intervention descriptions: intervention 1: 3 blue capsules of 25 mg given as a single dose intervention 2: 3 capsules of 25 mg given as a single dose intervention 3: 3 capsules of 25 mg given as a single dose

Protocol document: