Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg

NCT00648882 | Completed Phase 1

• 1 other identifier: LEVO-0711
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600 mcg dose (2 × 300 mcg) administered under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

LEVOTHYROXINE SODIUM TABLETS,USP 300 mcg;

Drug: LEVOTHYROXINE SODIUM TABLETS,

2

ACTIVE COMPARATOR

SYNTHROID® 300 mcg Tablets

Drug: SYNTHROID® 300 mcg Tablets

Interventions

LEVOTHYROXINE SODIUM TABLETS, DRUG

2x300mcg, single dose fasting

1

SYNTHROID® 300 mcg Tablets DRUG

2x300mcg, single dose fasting

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Institutionalized subjects will not be used.
• Social Habits:
• Use of any tobacco-containing products within 1 year of the start of the study.
• 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 or herbal products within 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• A positive test for any drug included in the urine drug screen.
• History of drug and/or alcohol abuse.
• Medications:
• Use of any prescription or over-the-counter (OTC) medications within the 30 days prior to the initial dose of study medication. These may include but is not limited to: infant soybean formula, steroids, salicylates, 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 hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
• 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 cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
• Acute illness at the time of either the pre-study medical evaluation or dosing.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

PRACS Institute Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Alan K Copa, Pharm. D.

  PRACS Institute Ltd. - Cetero Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)