Healthy
Conditions
Brief summary
Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration
Detailed description
Single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, single dose cross-over trial with administrations under fasting conditions separated by a washout period of at least 45 treatment-free days
Interventions
DRUGLevothyroxin
Single-dose administration of 600 mcg of Levothyroxin for the assessment of bioequivalence
Sponsors
Berlin-Chemie AG Menarini Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, single dose cross-over trial with administrations under fasting conditions separated by a washout period of at least 45 treatment-free days
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ethnic origin: Caucasian 2. age: 18 years or older 3. body-mass index (BMI): 18.5 kg/m² and 30.0 kg/m² 4. good state of health 5. non-smoker or ex-smoker for at least 3 months 6. written informed consent, must be signed and dated before enrolment by the subject and the (sub-)investigator, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
Exclusion criteria
Subjects cannot be included if they match any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-72 | 72 days | AUC0-72 of levothyroxine (baseline corrected) after each treatment |
| Cmax | 72 days | Cmax of levothyroxine (baseline corrected) after each treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCexpol% | 72 days | AUCexpol% of levothyroxine (baseline corrected) after each treatment |
| tmax | 72 days | tmax of levothyroxine (baseline corrected) after each treatment |
| AUC0-tlast | 72 days | AUC0-tlast of levothyroxine (baseline corrected) after each treatment |
| λz | 72 days | λz of levothyroxine (baseline corrected) after each treatment |
| tlag | 72 days | tlag of levothyroxine (baseline corrected) after each treatment |
| t1/2 | 72 days | t1/2 of levothyroxine (baseline corrected) after each treatment |
| AUC0-∞ | 72 days | AUC0-∞ of levothyroxine (baseline corrected) after each treatment |
Countries
Germany
Outcome results
None listed