Comparative assessment of the absorption of a generic formulation of (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid tablets against the innovator (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid tablets conducted under fasting conditions in healthy male and female volunteers
- Conditions
- (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid is used for the treatment of management of demonstrated thyroid hormone deficiency.Metabolic and Endocrine - Thyroid disease
- Registration Number
- ACTRN12620000191998
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Healthy males and females
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches, hypothyroidism, hyperthyroidism and/or cardiovascular disorders.
Concomitant drug therapy of any kind
Sensitivity to any of the medicines or ingredients
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 30 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to compare the bioavailability of (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid (as summarised by Cmax and AUC) for all formulations. All plasma samples will be assayed for (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[30, 15 and 5 mins pre-dose and at 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dosing.]
- Secondary Outcome Measures
Name Time Method The secondary outcome is measuring Time to maximum peak concentration (Tmax) in plasma for (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid combined in one assay. Tmax will be the time where the maximum concentration occurred in the sample points.[30, 15 and 5 mins pre-dose and at 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dosing.]