Clinical study on the insulin sensitizing effect of multiple administration of Vition (Meditop) in healthy human volunteers (Pilot study)

• Conditions: ow potassium and magnesium levels especially in chronic heart disease.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001859-36-HU
• Lead Sponsor: Meditop Pharmaceuticals Co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Healthy, male and female subjects 18 years of older age
•Body mass index within the range of 18.5 – 30
•Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method)
•Findings within the range of clinical acceptability in medical history and physical examination unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study; to be documented in writing
•Laboratory results within the normal ranges” for the relevant laboratory tests unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study; to be documented in writing (normal ranges are included in chapter 27.3)
•Normal ECG and vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study; to be documented in writing
•Willingness to undergo a pre-study physical examination and pre- and post-study laboratory investigations
•Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures)
•Preferably non-smokers or mild to moderate smokers (= 10 cigarettes daily).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Evidence or history of asthma, urticaria, or allergic-type reactions
•History of hypersensitivity to the study drug or any related drugs or to any of the excipients
•History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, or malignant disease or diabetes mellitus
•Clinically significant abnormal laboratory values, ECG findings, or vital signs during screening; clinically significant illness or minor surgery within 4 weeks prior to dosing
•History of, or current compulsive alcohol abuse (more than 10 drinks weekly); or regular exposure to other substances of abuse
•History of drug addiction, positive urine screen for drugs of abuse
•Smokers (more than 10 cigarettes)
•Donation or loss of blood equal to or exceeding 500 ml during 90 days before the first administration of study medication
•Positive testing for HIV, HBsAg and HCV
•Participation in another study with an experimental drug within at least 30 days (or within five elimination half lives of the previous experimental drug, whichever is longer) before the first administration of study medication
•Any use of drug, prescribed or OTC (inclusive herbal remedies), within 2 weeks (or within six elimination half lives of this medication, whichever is longer) prior to the first administration of study medication except if this will not affect the outcome of the study in the opinion of the clinical investigator
•Pregnant women (positive pregnancy test)
•Lactating women
•Unwillingness or inability to comply with the study protocol or study-related procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified