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MarketScreener Homepage  >  Equities  >  Xetra  >  Merck KGaA AG    MRK   DE0006599905

MERCK KGAA AG

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Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form: Immune System Diseases and Conditions - Allergies

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08/14/2019 | 05:47pm EDT

2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at Hepatitis Daily News -- Staff editors report on the newly launched clinical trial, NCT04037748, which has the following summary description: “The study is 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.”

As a matter of record, on July 31, 2019, NewsRx staff editors report that the available information provided by Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany on this trial include:

Tracking Information

Trial IdentifierNCT04037748
First Submitted DateJuly 26, 2019
First Posted DateJuly 30, 2019
Results First Submitted DateNot Provided
Results First Posted DateNot Provided
Last Update Submitted DateJuly 26, 2019
Last Update Posted DateJuly 30, 2019
Primary Completion DateSeptember 9, 2019
Actual Start DateJune 25, 2019
Current Primary Outcome Measures•Maximum Observed Plasma Concentration in Baseline Corrected Data (Cmax[adj]) of Levothyroxine (T4) [ Time Frame: Pre-dose to 72 hours post-dose ]
•Area Under The Plasma Concentration-time Curve From Time Zero to 72 Hours, in Baseline Corrected Data (AUC0-72 [adj]) of Levothyroxine (T4) [ Time Frame: Pre-dose to 72 hours post-dose ]
Current Secondary Outcome Measures•Time to Reach Maximum Plasma Concentration (tmax) of Levothyroxine (T4) [ Time Frame: Pre-dose to 72 hours post-dose ]
•Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours (AUC[0-72]) of Levothyroxine (T4) [ Time Frame: Pre-dose to 72 hours post-dose ]
•Maximum Observed Plasma Concentration (Cmax) of Levothyroxine (T4) [ Time Frame: Pre-dose to 72 hours post-dose ]
Other Outcome MeasuresNot Provided
Change HistoryComplete list of historical revisions of study NCT04037748

Descriptive Information

Brief TitleBioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Official TitleA Prospective, Single Dose, Randomized, Open-label, Crossover, Comparative Study to Establish Bioequivalence in Healthy Subjects Between the Puran T4® (Sanofi Aventis Farmaceutica Ltda) vs. the New Formulation of Levothyroxine (Eutirox NF® Merck) Administered Orally as 3 Tablets of 200 mg
Brief SummaryThe study is 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Other
Masking: None (Open Label)
ConditionHealthy
Intervention•Drug: Puran T4®
Participants will receive single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2.
•Drug: Eutirox®
Participants will receive single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2.
Study Arms•Experimental: First Eutirox®, then Puran T4®
Participants will receive single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxi
Interventions:
⚬Drug: Puran T4®
⚬Drug: Eutirox®
•Experimental: First Puran T4®, then Eutirox®
Participants will receive single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxi
Interventions:
⚬Drug: Puran T4®
⚬Drug: Eutirox®

Recruitment Information

Recruitment StatusRecruiting
Estimated Enrollment72
Estimated Completion DateSeptember 9, 2019
Primary Completion DateSeptember 9, 2019 (Final data collection date for primary outcome measure)
EligibilityInclusion Criteria:
•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
•Other protocol defined inclusion criteria could apply Exclusion Criteria:
•Supplementary tests results out of the values considered as normal, unless considered clinically irrelevant
•Research participants who are submitted to surgery before the beginning of the study will be carefully evaluated by the doctor regarding the enrollment in the study complying to an exclusion period ranging from 4 to 8 weeks
•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)
•Participants that prior to the dosing takes any other medication and had not passed at least seven half-lives of elimination of the drug, in this case, be considered by the Principal Investigator the non-inclusion of the participant in the study. Participants taking medications known to affect thyroid hormone metabolism, e.g., oral contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens, etc., or the bioavailability of levothyroxine like proton pump Inhibitors
•Has a history of alcohol abuse or has ingested alcohol 24 hours previous to the hospitalization period
•Other protocol defined exclusion criteria could apply
Sex/GenderSexes Eligible for Study: All
Ages18 years to 50 years
Accepts Healthy VolunteersYes
ContactsPrimary contact: Communication Center, +49 6151 72 5200, service@emdgroup.com
Listed Location CountriesBrazil
Removed Location Countries

Administrative Information

NCT NumberNCT04037748
Other Study ID NumbersMS200125_0014
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
Plan to Share DataNo
Plan to Share Data (IPD) DescriptionPer company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be is found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Responsible PartyMerck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
CollaboratorsNot Provided
InvestigatorsStudy Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Information Provided ByMerck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Verification DateJuly 2019

(Our reports deliver fact-based news of research and discoveries from around the world.)

Copyright © 2019 NewsRx LLC, Hepatitis Daily News, source Health Newsletters

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Financials (EUR)
Sales 2019 15 629 M
EBIT 2019 2 208 M
Net income 2019 1 491 M
Debt 2019 6 035 M
Yield 2019 1,37%
P/E ratio 2019 27,2x
P/E ratio 2020 22,4x
EV / Sales2019 3,00x
EV / Sales2020 2,74x
Capitalization 40 826 M
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Stefan Oschmann Chairman-Executive Board & CEO
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