Low potassium and magnesium levels especially in chronic heart disease.
Conditions
Interventions
Trade Name: Vition (Meditop)
Product Name: Vition
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Meditop Pharmaceuticals Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the putative insulin sensitizing effect of Vition in healthy volunteers by means of hyperinsulinaemic euglycaemic glucose clamping. ;Secondary Objective: To assess the metabolic safety of repetitive Vition administration. ;Primary end point(s): Insulin sensitivity index (glucose infusion rate) serves also as characterising efficacy by proving and quantifying the suspected insulin sensitising effect of Vition treatment. ;Timepoint(s) of evaluation of this end point: The blood samples will be taken at the prescribed time-points (after both - test and reference - medication). After the study the blood levels will be analyzed and the PK calculations performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The data will be tabulated with descriptive group statistics (mean, standard deviation, minimum, maximum, number of valid cases). Possible side effects of the study medication and any adverse event will be listed. Insulin sensitivity index (glucose infusion rate) for characterizing overall metabolic hazard. ;Timepoint(s) of evaluation of this end point: The blood samples will be taken at the prescribed time-points. After the study the blood levels will be analyzed and the PK calculations performed. | — |
Countries
Hungary
Contacts
Public ContactClinical Trials Information
PRS Ltd.
Outcome results
None listed