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A Dose Block-randomized, Double-blind, Placebo- and Active-controlled, Single and Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

ClinicalTrials.gov · COMPLETED, 2017

120 participants

Abstract

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers.

Conditions: Healthy.

Primary outcome: Number and percentage of Participants With Adverse Events (AE); Number and percentage of Participants With Adverse Drug Reactions (ADR); Number of Participants With Clinically Significant Vital Sign findings; Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings; Number of Participants With Clinically Significant Laboratory results.

Enrollment: 120 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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