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Clinical Trial Summary

This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine


Clinical Trial Description

Setting The study was conducted on the clinical research unit of an academic medical center.

Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.

Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.

Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03102177
Study type Interventional
Source Georgetown University
Contact
Status Completed
Phase Early Phase 1
Start date May 31, 2011
Completion date July 26, 2016

See also
  Status Clinical Trial Phase
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Recruiting NCT06276205 - Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism Phase 3