A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole
Abstract
This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.
Conditions: Safety Issues.
Primary outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Enrollment: 28 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 28 participants or records.
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