Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form

NCT04037748 | Completed Phase 1 Results

• 1 other identifier: MS200125_0014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study was to verify if the test formulation of Levothyroxine sodium presents an equivalent rate and extension of absorption to the comparator formulation when administered with the same dosage and under fasting conditions and after baseline correction concentrations.

Conditions

Healthy

Keywords

Eutirox®; Puran T4®; Levothyroxine

Outcome Measures

Primary Outcomes (2)

• Baseline Corrected Maximum Observed Plasma Concentration (Cmax[Adj]) of Levothyroxine Sodium

  Cmax was obtained from plasma concentration time curve. Maximum plasmatic concentration observed adjusted by basal level correction was reported.

  Pre-dose, 24, 36, 48 and 72 hours post-dose

• Baseline Corrected Area Under The Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC0-72 [Adj]) of Levothyroxine Sodium

  The AUC 0-72 was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours post-dose. Area under the plasma curve from time 0 hours to time 72 hours adjusted by basal levels correction was reported.

  Pre-dose, 24, 36, 48 and 72 hours post-dose

Secondary Outcomes (3)

• Time to Reach Maximum Plasma Concentration (Tmax) of Levothyroxine Sodium

  Pre-dose, 24, 36, 48 and 72 hours post-dose

• Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC 0-72) of Levothyroxine Sodium

  Pre-dose, 24, 36, 48 and 72 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of Levothyroxine Sodium

  Pre-dose, 24, 36, 48 and 72 hours post-dose

Study Arms (2)

First Puran T4®, then Eutirox®

EXPERIMENTAL

Participants received single oral dose of Puran T4® 600 micrograms (mcg) (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.

Drug: Puran T4®; Drug: Eutirox®

First Eutirox®, then Puran T4®

EXPERIMENTAL

Participants received single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Puran T4® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.

Drug: Puran T4®; Drug: Eutirox®

Interventions

Puran T4® DRUG

Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.

First Eutirox®, then Puran T4®; First Puran T4®, then Eutirox®

Eutirox® DRUG

Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.

First Eutirox®, then Puran T4®; First Puran T4®, then Eutirox®

Eligibility Criteria

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

You may qualify if:

• To have freely agreed and signed the consent form, after all essential elements of the protocol have been clarified, before any procedure
• Body Mass Index (BMI) of the research participants must be comprised within the range of 18.50 to 27.00
• No abnormal findings on medical history that, in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation
• Normal vital signs: heart rate between 50 and 100 beats per minute; Systolic pressure between 80 and 129 millimeters of mercury (mmHg); diastolic pressure between 50 and 89 mmHg; temperature between 36.0 and 37.0 degrees Celsius
• Electrocardiogram (ECG) normal (abnormalities, even if clinically not relevant, are not permitted \[example {e.g.}: PR, QRS, QT, QTcF\] should be within normal range, no conduction abnormalities etcetera \[etc.\])
• All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator

You may not qualify if:

• Supplementary tests results out of the values considered as normal, unless considered clinically irrelevant
• Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) in pre-study tests
• Participants with a history of hypersensitivity/allergy to study drug or excipients, history or presence of asthma or any serious allergy (requiring hospitalization or prolonged systemic treatment), any food allergy or intolerance which in the opinion of the Investigator represents a safety risk (e.g., iodine allergy, etc.)
• Has participated in any experimental trial or has taken any experimental drug within 6 months previous to this study (RDC \[resolution of the collegiate board\] Resolution 34, dated June 3, 2008)
• Has a history of alcohol abuse or has ingested alcohol 24 hours previous to the hospitalization period

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

Aparecida de Goiânia, Brazil

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

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

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: June 25, 2019
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)