A Phase 4 interventional study of Drug Levothyroxine 150 mcg and Drug Eutirox 150 mcg in Healthy, sponsored by Tecnoquimicas. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Tecnoquimicas · Phase 4, Interventional, and Treatment
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine administration (e.g. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Tecnoquimicas modified its Levothyroxine tablets formulation in order to comply with new pharmacopeical specifications. It will then evaluate the impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test formulation) relative to the reference formulation from Merck (Reference formulation)
This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a single dose (4 x 150 mcg tablets = 600 mcg) of the test formulation of levothyroxine and reference formulation of levothyroxine separately in each treatment period. There will be two treatment sequences (AB, BA) and a 42 day washout between the two treatment periods.
Tecnoquimicas is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
Drug: Drug Levothyroxine 150 mcg
Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
Drug: Drug Eutirox 150 mcg
Administration of a 600 mcg levothyroxine dose
Administration of a 600 mcg levothyroxine dose
(AUC) Area Under the Curve 0-48 for T4
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Time frame: From 0 to 48 hours
Cmax for T4
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Time frame: From 0 to 48 hours
AUC 0-48 for T3
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Time frame: From 0 to 48 hours
Cmax for T3
Time frame: From 0 to 48 hours
Tmax
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Time frame: From 0 to 48 hours
Kel
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Time frame: From 0 to 48 hours
Plan to share: No
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This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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