HealthyPhase 1NCT00648557
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
A Phase 1 study testing Levothyroxine Sodium Tablets 200 mg and Synthroid Tablets 200 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Levothyroxine Sodium Tablets 200 mg and Synthroid Tablets 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Mar 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-50 years.
- Sex: Men and/or non-pregnant, non-lactating women.
- Women of childbearing potential must have negative serum β human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to each dose administration. An additional serum (β HCG) pregnancy test will be performed upon completion of the study.
- Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Oral contraceptives are not to be used within 3 months prior to dosing and throughout the course of the study due to the fact that they increase serum TBG concentrations, and therefore, elevate T4. Acceptable forms of contraception include the following:
- intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- barrier methods containing or used in conjunction with a spermicidal agent, or
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- postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy).
- Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women, and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1983 (See Part II Administrative Aspects of Bioequivalence Protocols).
- All subjects should be judged normal (euthyroid) and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation, blood chemistry, serum T4 (free and total), serum T3 (total only), serum thyroid-stimulating hormone (TSH), serum thyroxine-binding globulin (TBG), hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Who cannot join
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco products within 1 year of the initial study drug administration.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins within the 48 hours prior to the initial dose of the study medication.
- Any change in dietary or exercise habits throughout the duration of the study.
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- Medications:
- Use of any medication within the last 30 days prior to the initial dose of study medication, during the study or during the washout period. These may include but is not limited to: infant soybean formula, steroids, salicylates, androgenic or estrogenic hormones including oral contraceptives; preparations containing iodine, such as vitamins; oral anti-diabetic agents; all resins for lowering of cholesterol, such as cholestyramine; sucralfate, propranolol, amiodarone, phenytoin, carbamazepine, furosemide; aluminum-containing antacids, including aluminum hydroxide; rifampin, calcium channel blockers and ferrous sulfate.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Diseases:
- History of any significant chronic disease and/or hepatitis.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the prestudy medical evaluation or dosing.
- History of any thyroid disease.
- Subjects with any underlying medical condition known to interfere with the absorption or metabolism of thyroid hormones.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide for Clinically Relevant Abnormalities (See Part II Administrative Aspects of Bioavailability Protocols).
- Abnormal and clinically relevant ECG tracing.
- Abnormal thyroid function tests.
- Donation or loss of a significant volume of blood or plasma (> 450 ml) within 28 days prior to the initial dose of study medication.
- Subjects who received any surgical treatment within 6 months prior to the initial dose of study medication.
- Subjects with known allergies or hypersensitivity to thyroid preparations.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Levothyroxine Sodium Tablets (200 mg; Mylan) to Synthroid Tablets (200 mg; Abbott) in Healthy Volunteers
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions
- Conditions
- Healthy
- Being tested
- Levothyroxine Sodium Tablets 200 mg, Synthroid Tablets 200 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine Sodium Tablets 200 mgDrug
3x200mcg, single dose fasting
Synthroid Tablets 200 mgDrug
3x200mcg, single dose fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levothyroxine Sodium Tablets 200 mg Receives: Drug: Levothyroxine Sodium Tablets 200 mg |
| 2 | Active comparator | Synthroid Tablets 200 mg Receives: Drug: Synthroid Tablets 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2003
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D Carlson, Pharm. D., Principal investigator, PRACS Institute Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648557
- Sponsor's protocol ID
- LEVO-02144
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fasting In Vivo Bioequivalence Study of Levothyroxine Sodium Tablets (200 mg; Mylan) to Synthroid Tablets (200 mg; Abbott) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00648557
- Acronym / sponsor ID
- LEVO-02144
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levothyroxine Sodium Tablets 200 mgLevothyroxine Sodium Tablets 200 mg |
| 2 | Active comparator | Drug: Synthroid Tablets 200 mgSynthroid Tablets 200 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-50 years.
- Sex: Men and/or non-pregnant, non-lactating women.
- Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women, and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1983 (See Part II Administrative Aspects of Bioequivalence Protocols).
- All subjects should be judged normal (euthyroid) and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation, blood chemistry, serum T4 (free and total), serum T3 (total only), serum thyroid-stimulating hormone (TSH), serum thyroxine-binding globulin (TBG), hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Key exclusion criteria (23 listed)
- Institutionalized subjects will not be used.
- Social Habits:
- Medications:
- Diseases:
- Abnormal and clinically significant laboratory test results:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxine Sodium Tablets 200 mg3x200mcg, single dose fasting | Drug | 1 |
| Synthroid Tablets 200 mg3x200mcg, single dose fasting | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Carlson, Pharm. D. principal investigator
PRACS Institute Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levothyroxine Sodium Tablets 200 mg and Synthroid Tablets 200 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.