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Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM

27. marts 2018 opdateret af: Elcelyx Therapeutics, Inc.

Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus

The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

571

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Forenede Stater, 35216
        • Achieve Clinical Research, LLC
      • Birmingham, Alabama, Forenede Stater, 35209
        • Central Alabama Research
      • Tuscumbia, Alabama, Forenede Stater, 35674
        • Terence T. Hart, MD
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Radiant Research - Phoenix
      • Glendale, Arizona, Forenede Stater, 85306
        • Arrowhead Health Centers
      • Peoria, Arizona, Forenede Stater, 85381
        • Holland Center for Family Health, LTD
      • Phoenix, Arizona, Forenede Stater, 85018
        • Elite Clinical Studies
      • Phoenix, Arizona, Forenede Stater, 85037
        • Thunderbird Internal Medicine - Indian School Rd.
      • Surprise, Arizona, Forenede Stater, 85374
        • Clinical Research Institute of Arizona, LLC
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • Summit Clinical Trials Center
      • Searcy, Arkansas, Forenede Stater, 72143
        • Searcy Medical Center
    • California
      • Escondido, California, Forenede Stater, 92025
        • Advanced Metabolic Care & Research Institute (AMCR)
      • Fountain Valley, California, Forenede Stater, 92708
        • MD Studies, Inc.
      • Huntington Park, California, Forenede Stater, 90255
        • National Research Institute
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Whittier Diabetes Institute
      • Lincoln, California, Forenede Stater, 95648
        • Clinical Trials Research
      • Long Beach, California, Forenede Stater, 90806
        • Collaborative Neuroscience Network, LLC
      • Los Angeles, California, Forenede Stater, 90057
        • National Research Institute
      • Montclair, California, Forenede Stater, 91763
        • Catalina Research Institute
      • National City, California, Forenede Stater, 91950
        • SRSD, Inc. dba Synergy San Diego
      • North Hollywood, California, Forenede Stater, 91606
        • Providence Clinical Research
      • Oakland, California, Forenede Stater, 94607
        • Pacific Research Partners, LLC
      • Orange, California, Forenede Stater, 92868
        • SDS Clinical Trials, Inc.
      • Sacramento, California, Forenede Stater, 95825
        • Superior Research LLC
      • Sacramento, California, Forenede Stater, 95823
        • Center for Clinical Trials of Sacramento
      • Sacramento, California, Forenede Stater, 95823
        • Center for Clinical Trials of Scaramento
      • Santa Ana, California, Forenede Stater, 92705
        • Syrentis Clinical Research (formerly Research Across America)
      • Spring Valley, California, Forenede Stater, 91978
        • Encompass Clinical Research
      • Tustin, California, Forenede Stater, 92780
        • Clinical Trial Investigators
      • Van Nuys, California, Forenede Stater, 91405
        • Infosphere Clinical Research
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80906
        • Colorado Springs Health Partners
      • Denver, Colorado, Forenede Stater, 80209
        • Creekside Endocrine Associates
    • Florida
      • Brooksville, Florida, Forenede Stater, 34601
        • Meridien Research - Brooksville
      • Cooper City, Florida, Forenede Stater, 33024
        • ALL Medical Research, LLC
      • Hialeah, Florida, Forenede Stater, 33012
        • Neostart Corporation dba AGA Clinical Trials
      • Jacksonville, Florida, Forenede Stater, 32277
        • Care Partners Clinical Research
      • Jupiter, Florida, Forenede Stater, 33458
        • Health Awareness, Inc.
      • Kissimmee, Florida, Forenede Stater, 34741
        • Family Health Care Clinical Studies
      • Lakeland, Florida, Forenede Stater, 33810
        • Clinical Research of Central Florida-Lakeland
      • Miami, Florida, Forenede Stater, 33014
        • Clinical Pharmacology of Miami, Inc.
      • Miami, Florida, Forenede Stater, 33173
        • Tellus Clinical Research, Inc.
      • Miami, Florida, Forenede Stater, 33183
        • Internal Research Associates LLC - Breton
      • Orlando, Florida, Forenede Stater, 32801
        • Clinical Neuroscience Solutions, Inc. Healthcare Orlando
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Pembroke Pines, Florida, Forenede Stater, 33026
        • Private Practice - Andres Patron, DO
      • Port Orange, Florida, Forenede Stater, 32127
        • Progressive Medical Research
      • Saint Petersburg, Florida, Forenede Stater, 33709
        • Meridien Reserach - St. Petersburg
      • Tampa, Florida, Forenede Stater, 33634
        • Meridien Research - Tampa
      • Tampa, Florida, Forenede Stater, 33607
        • Clinical Reserch Trials of Florida
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Metabolic Research Institute, Inc.
    • Illinois
      • Addison, Illinois, Forenede Stater, 60101
        • Biofortis, Inc.
      • Aurora, Illinois, Forenede Stater, 60506
        • AMR Sakeena Research
      • Chicago, Illinois, Forenede Stater, 60607
        • Cedar-Crosse Research Center
      • Evanston, Illinois, Forenede Stater, 60201
        • Evanston Premier Healthcare Research LLC
    • Indiana
      • Valparaiso, Indiana, Forenede Stater, 46383
        • Buynak Clinical Research, PC
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • The Iowa Clinic; Cardiovascular Services
    • Kansas
      • Augusta, Kansas, Forenede Stater, 67010
        • Heartland Research Associates, LLC - Augusta
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • Otrimed
      • Lexington, Kentucky, Forenede Stater, 40503
        • Kentucky Diabetes Endocrinology Center
      • Louisville, Kentucky, Forenede Stater, 40213
        • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
      • Paducah, Kentucky, Forenede Stater, 42003
        • Four Rivers Clinical Research
    • Louisiana
      • Crowley, Louisiana, Forenede Stater, 70526
        • Avant Research Associates
      • Lake Charles, Louisiana, Forenede Stater, 70601
        • Centex Studies, Inc. - Lake Charles
    • Maryland
      • Columbia, Maryland, Forenede Stater, 21045
        • Columbia Medical Practice
      • Hyattsville, Maryland, Forenede Stater, 20782
        • MedStar Health Research Institute
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Md Medical Research
    • Massachusetts
      • Quincy, Massachusetts, Forenede Stater, 02169
        • Beacon Clinical Research
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Radiant Research - Edina
    • Mississippi
      • Port Gibson, Mississippi, Forenede Stater, 39150
        • Planters Clinic
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Quality Clinical Research, Inc.
      • Omaha, Nebraska, Forenede Stater, 68134
        • Heartland Clinical Research
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Alliance Against Diabetes
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Palm Medical Research
      • Las Vegas, Nevada, Forenede Stater, 89146
        • Ingham Neuroscience Group, LLC
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Comprehensive Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Albuquerque Neuroscience, Inc.
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Albuquerque Clinical Trials
    • New York
      • Brooklyn, New York, Forenede Stater, 11235
        • NY Scientific
      • Great Neck, New York, Forenede Stater, 11023
        • Long Island Gastrointestinal Research Group
      • Hopewell Junction, New York, Forenede Stater, 12533
        • Mid-Hudson Medical Research, PLLC
      • Westfield, New York, Forenede Stater, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • PharmQuest
      • Greensboro, North Carolina, Forenede Stater, 27410
        • Triad Clinical Trials LLC
      • Rocky Mount, North Carolina, Forenede Stater, 27804
        • PMG Research of Rocky Mount
      • Salisbury, North Carolina, Forenede Stater, 28144
        • PMG Research of Salisbury, LLC
      • Wilmington, North Carolina, Forenede Stater, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45242
        • New Horizons Clinical Research
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Sterling Research Group, Ltd
      • Cincinnati, Ohio, Forenede Stater, 45227
        • Metabolic Atherosclerosis Research Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
      • Franklin, Ohio, Forenede Stater, 45005
        • Prestige Clinical Research
      • Huber Heights, Ohio, Forenede Stater, 45424
        • Hometown Urgent Care and Research - Huber Heights
      • Marion, Ohio, Forenede Stater, 43302
        • RAS Health LTD
      • Stow, Ohio, Forenede Stater, 44224
        • Summit Reserach Group, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • COR Clinical Research, LLC
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • Willamette Valley Clinical Studies
    • Pennsylvania
      • Downingtown, Pennsylvania, Forenede Stater, 19335
        • Brandywine Clinical Research
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Medical Research South, LLC
      • Greer, South Carolina, Forenede Stater, 29651
        • Mountain View Clinical Research - Greer
      • Mount Pleasant, South Carolina, Forenede Stater, 29464
        • PMG of Charleston, LLC
      • Myrtle Beach, South Carolina, Forenede Stater, 29588
        • Family Medicine of SayeBrook, LLC
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • Hillcrest Clinical Research, LLC
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Research
      • Spartanburg, South Carolina, Forenede Stater, 29301
        • Palmetto Proactive Healthcare, LLC
      • Summerville, South Carolina, Forenede Stater, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • PMG Research of Bristol, LC - State
      • Knoxville, Tennessee, Forenede Stater, 37912
        • PMG Research of Knoxville
      • Memphis, Tennessee, Forenede Stater, 38119
        • Clinical Neuroscience Solutions, Inc. - Memphis
      • Tullahoma, Tennessee, Forenede Stater, 37388
        • Trinity Clinical Research
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Central Texas Clinical Research
      • Carrollton, Texas, Forenede Stater, 75007
        • Trinity Universal Research Associates, Inc.
      • Dallas, Texas, Forenede Stater, 75230
        • Dallas Diabetes and Endocrine Center
      • Dallas, Texas, Forenede Stater, 75231
        • Research Institute Of Dallas
      • Dallas, Texas, Forenede Stater, 75251
        • Galenos Research
      • Houston, Texas, Forenede Stater, 77058
        • Centex Studies, Inc.
      • Houston, Texas, Forenede Stater, 77036
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network - Houston
      • Houston, Texas, Forenede Stater, 77074
        • Juno Research, LLC-Houston
      • Katy, Texas, Forenede Stater, 77450
        • Juno Research, LLC-Katy
      • San Antonio, Texas, Forenede Stater, 78215
        • Sun Research Institute
      • San Antonio, Texas, Forenede Stater, 78231
        • Victorium Clinical Research
      • San Antonio, Texas, Forenede Stater, 78207
        • Texas Diabetes Institute Research Center
      • Shavano Park, Texas, Forenede Stater, 78231
        • Consano Clinical Research
      • Sugar Land, Texas, Forenede Stater, 77478
        • Southwest Health Associates, P.A.
    • Utah
      • Saint George, Utah, Forenede Stater, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Burke, Virginia, Forenede Stater, 22015
        • Burke Internal Medicine & Research
      • Manassas, Virginia, Forenede Stater, 20110
        • Manassas Clinical Research Center
      • Richmond, Virginia, Forenede Stater, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Universal Research Group, LLC
  • Puerto Rico
      • Carolina, Puerto Rico, 00987
        • Puerto Rico Renal and Health Research, Inc.
      • Cidra, Puerto Rico, 00736
        • Advanced Medical Concepts
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Reserach Doctor's Center Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Is at least 25 years old at Visit 1 (Screening).

  2. Is male, or is female and meets all of the following criteria:

    1. Not breastfeeding
    2. Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
    3. Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.
  3. Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
  4. Has a physical examination with no clinically significant abnormalities as judged by the investigator.
  5. Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
  6. Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation.

  7. Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Visit 1:

    1. Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
    2. Hormone replacement therapy (female subjects) and testosterone (male subjects)
    3. Oral contraceptives (female subjects)
    4. Antihypertensive agents
    5. Lipid-lowering agents
    6. Thyroid replacement therapy
    7. Antidepressant agents
  8. Ability to understand and willingness to adhere to protocol requirements.

Exclusion Criteria:

  1. Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:

    1. Hepatic disease
    2. Gastrointestinal disease
    3. Endocrine disorder (T2DM is allowed)
    4. Cardiovascular disease
    5. Central nervous system diseases
    6. Psychiatric or neurological disorders
    7. Organ transplantation
    8. Chronic or acute infection
    9. Orthostatic hypotension, fainting spells or blackouts
    10. Allergy or hypersensitivity.
  2. A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
  3. Prior major surgery of any kind within 6 months of Visit 1.
  4. A history of >3% weight change within 3 months of Visit 1.
  5. A clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormality, other than that related to T2DM, judged by the investigator to be clinically significant at Visit 1.
  6. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
  7. A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.

  8. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:

    1. Metformin within 2 months of Visit 1 (Screening)
    2. Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
    3. Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
    4. Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit 1.
    5. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of Visit 1
    6. Planned use of any drug treatment that affects gastric pH (prescription or over-the-counter), such as H2-receptor antagonists and proton pump inhibitors, after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than twice per week) after Visit 2 (Week -2)
    7. Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit 1.
    8. Iodinated contrast dye within 1 week prior to Visit 1.
    9. Investigational drug within 2 months (or five half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication.
    10. Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1 (Screening)
  9. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures.
  10. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 2 months prior to Visit 1 (Screening), or is planning to donate blood during the study.
  11. Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
  12. Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
  13. Has a fasting plasma glucose value >270 mg/dL at Visit 1 (Screening), Visit 2 (Week -2), and an unscheduled visit to be completed within 1 week following Visit 2. The unscheduled visit is to be completed only for subjects with a fasting plasma glucose value >270 mg/dL at Visit 1 and Visit 2.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
Medicin: Mødte DR
metformin tabletter med forsinket frigivelse
Eksperimentel: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
Medicin: Mødte DR
metformin tabletter med forsinket frigivelse
Eksperimentel: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
Medicin: Mødte DR
metformin tabletter med forsinket frigivelse
Eksperimentel: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
Medicin: Mødte DR
metformin tabletter med forsinket frigivelse
Placebo komparator: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
Medicin: Placebo
Placebo komparator: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
Medicin: Placebo
Aktiv komparator: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
Medicin: Met IR
metformin immediate-release tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in HbA1c (%) at 16 Weeks
Tidsramme: Baseline and 16 weeks after the first dose of study medication
Baseline and 16 weeks after the first dose of study medication

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elcelyx Therapeutics, Inc.

Efterforskere

  • Ledende efterforsker: Juan P Frias, MD, National Research Institute - Wilshire

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

16. august 2015

Først indsendt, der opfyldte QC-kriterier

17. august 2015

Først opslået (Skøn)

18. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCRM112

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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