NCT00648557

CompletedPhase 1

Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synt...

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

LEVO-02144

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

January 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2003

Actual (reported)

Study Completion

March 2003

Actual (reported)

Brief 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. 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: March 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2003
Actual (reported)
Study Completion
March 2003
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 24, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Levothyroxine Sodium Tablets 200 mg

Drug: Levothyroxine Sodium Tablets 200 mg

2

ACTIVE COMPARATOR

Synthroid Tablets 200 mg

Drug: Synthroid Tablets 200 mg

Interventions

Levothyroxine Sodium Tablets 200 mgDrug

3x200mcg, single dose fasting

1

Synthroid Tablets 200 mgDrug

3x200mcg, single dose fasting

2

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age: 18-50 years.
Sex: Men and/or non-pregnant, non-lactating women.

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

James D Carlson, Pharm. D.
PRACS Institute Ltd.
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

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

January 2003

Date type not reported

This date has not been verified as actual or estimated.

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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 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.
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.
+8 more criteria

Contact the study team to confirm eligibility.

Primary Completion

March 2003

Actual (reported)

Study Completion

March 2003

Actual (reported)

Last Updated

April 24, 2024

Record last verified: 2024-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00648557
Data provider: ClinicalTrials.gov
Source updated: 2024-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:47 UTC

Locations

US(1)

Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations