CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Methylene Bluedrug
Likely dose
Not stated in 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.

Search/NCT02478281
NCT02478281Phase 1Completed
CompareCT.gov

A One-Period, Single-Dose, Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Injection United States Pharmacopeia (USP) Following a 1 mg/kg Intravenous Dose in Healthy Adult Volunteers

American Regent, Inc.·interventional·Posted Jun 23, 2015·Updated Jun 5, 2025

In Brief

A Phase 1 clinical trial evaluating Methylene Blue for Methemoglobinemia and Congenital Methemoglobinemia. Completed, enrolled 12 participants.

Detailed Summary

A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of Methylene Blue Injection, USP 1 mg/kg in healthy adult volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethemoglobinemia, Congenital Methemoglobinemia
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.0 years ago

Interventions

Methylene Bluedrug