Pharmacokinetics of AZD7295 Capsules
This study has been completed.
Information provided by:
First received: March 30, 2010
Last updated: August 6, 2010
Last verified: August 2010
This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers|
Further study details as provided by Arrow Therapeutics:
Primary Outcome Measures:
- Pharmacokinetics of AZD7295 capsules [ Time Frame: 0-72h after each dose ] [ Designated as safety issue: No ]PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2)
Secondary Outcome Measures:
- Safety and tolerability of AZD7295 capsules [ Time Frame: 0-72h after each dose ] [ Designated as safety issue: Yes ]Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests)
|Study Start Date:||March 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.
|Placebo Comparator: Matched placebo||
Drug: Placebo comparator
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