Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
The study was to verify if the test formulation of Levothyroxine sodium presents an
 equivalent rate and extension of absorption to the comparator formulation when administered
 with the same dosage and under fasting conditions and after baseline correction
 concentrations.
Inclusion Criteria:

 -  To have freely agreed and signed the consent form, after all essential elements of the
 protocol have been clarified, before any procedure

 -  Body Mass Index (BMI) of the research participants must be comprised within the range
 of 18.50 to 27.00

 -  No abnormal findings on medical history that, in the opinion of the investigator,
 constitutes a risk or a contraindication for the participation of the participant in
 the study or that could interfere with the study objectives, conduct or evaluation

 -  Normal vital signs: heart rate between 50 and 100 beats per minute; Systolic pressure
 between 80 and 129 millimeters of mercury (mmHg); diastolic pressure between 50 and 89
 mmHg; temperature between 36.0 and 37.0 degrees Celsius

 -  Electrocardiogram (ECG) normal (abnormalities, even if clinically not relevant, are
 not permitted [example {e.g.}: PR, QRS, QT, QTcF] should be within normal range, no
 conduction abnormalities etcetera [etc.])

 -  All values for biochemistry and hematology tests of blood and urine within the normal
 range or showing no clinically relevant deviation as judged by the Investigator

 -  Other protocol defined inclusion criteria could apply

 Exclusion Criteria:

 -  Supplementary tests results out of the values considered as normal, unless considered
 clinically irrelevant

 -  Research participants who are submitted to surgery before the beginning of the study
 will be carefully evaluated by the doctor regarding the enrollment in the study
 complying to an exclusion period ranging from 4 to 8 weeks

 -  Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) in
 pre-study tests

 -  Participants with a history of hypersensitivity/allergy to study drug or excipients,
 history or presence of asthma or any serious allergy (requiring hospitalization or
 prolonged systemic treatment), any food allergy or intolerance which in the opinion of
 the Investigator represents a safety risk (e.g., iodine allergy, etc.)

 -  Has participated in any experimental trial or has taken any experimental drug within 6
 months previous to this study (RDC [resolution of the collegiate board] Resolution 34,
 dated June 3, 2008)

 -  Participants that prior to the dosing takes any other medication and had not passed at
 least seven half-lives of elimination of the drug, in this case, be considered by the
 Principal Investigator the non-inclusion of the participant in the study. Participants
 taking medications known to affect thyroid hormone metabolism, e.g., oral
 contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens,
 etc., or the bioavailability of levothyroxine like proton pump Inhibitors

 -  Has a history of alcohol abuse or has ingested alcohol 24 hours previous to the
 hospitalization period

 -  Other protocol defined exclusion criteria could apply