Bioequivalence study of levothyroxine 100 mcg tablets

Not Applicable

Recruiting

• Conditions: ..

• Registration Number: IRCT20130626013776N113
• Lead Sponsor: Alborroz Zags Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

18-55 years of age
The subject is able and willing to provide signed informed consent
Willing to adhere to protocol requirements as evidenced by written informed consent
The subject has a stable residence and telephone
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening

Exclusion Criteria

History of allergy or sensitivity to levothyroxine
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject of the study
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
Presence of gastrointestinal disease or history of malabsorption within the last year
History of a medical disorders occurring within the last year that required hospitalization or medication
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing
Receipt of any drug as part of a research study within 30 days prior to the present study
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum serum drug concentration. Timepoint: At time -0.5, -0.25, zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations.;Area under serum concentration-time curve. Timepoint: At time -0.5, -0.25, zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations.

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax. Timepoint: At time -0.5, -0.25, zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations.;Serum half-life. Timepoint: By using concentration at time points of 6, 8, 10, 24 and 48. Method of measurement: Blood sampling and drug analysis.