Status:
COMPLETED
Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers
Lead Sponsor:
PHARMENTERPRISES LLC
Conditions:
Metabolic Syndrome
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of Treamid after single and repeated oral administration in healthy volunteers...
Detailed Description
1 Russian center was approved for participation in this study and was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multi...
Eligibility Criteria
Inclusion
- Non-smoking male at the age from 18 to 50 years old (inclusive);
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass index from 18.5 to 30 kg/m2 (inclusive);
- Agreement to use adequate contraception methods during the study and 3 months after its completion (condoms with spermicide);
- Signed patient explanation sheet and informed consent for participation in the study.
Exclusion
- Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems and diseases of the gastrointestinal tract, liver, kidneys, blood;
- Laboratory deviations from normal values at screening (the deviations will not include single violations of reference ranges of laboratory parameter if they are not accompanied with any clinical symptoms, do not require additional examination or treatment and are not confirmed by values of related laboratory parameters);
- Regular administration of drugs in less than 2 weeks before starting the study; administration of drugs effecting on hemodynamics, liver function, and others. (barbiturates, omeprazole, cimetidine, etc.) in less than 30 days before starting the study;
- Antibodies to HIV and hepatitis C, hepatitis B surface antigen, positive test for syphilis;
- Unstable sleep architecture (e.g. night work, sleep disorders, insomnia, recently returned from another time zone, etc.);
- Signs of alcohol or drug addiction; taking alcohol or narcotic drugs during 4 days prior to screening (taking more than 10 units of alcohol per week (1 unit of alcohol is equivalent ½ liters of beer, 200 ml of wine or 50 ml of hard alcoholic beverages);
- Medical history significant for allergic (including drug intolerance and food allergies);
- Symptomatic rhinitis in past medical history during 2 years before screening (allergic rhinitis, non-allergic rhinitis or allergic coryza);
- Blood/plasma donation (from 450 ml) in less than 2 months prior to screening;
- Surgeries in hospital environment (except appendectomy) during 12 weeks prior to screening;
- Participation in other clinical studies or taking other investigated drugs during 3 months prior to screening;
- Inability to understand or comply with the protocol procedures;
- Acute infectious diseases in less than 4 weeks prior to screening.
Key Trial Info
Start Date :
January 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04428593
Start Date
January 25 2016
End Date
November 21 2016
Last Update
June 17 2020
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