Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults
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
Sponsor: American Regent, Inc.
Listed as NCT02478281, this PHASE1 trial focuses on Congenital Methemoglobinemia and Methemoglobinemia and remains completed. Sponsored by American Regent, Inc., it has been updated 8 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
8 versions recorded-
Jul 2025 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Jul 2025 [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Feb 2019 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 3 earlier versions
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Jun 2018 — Feb 2019 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Oct 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- American Regent, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.