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Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

NCT04428593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-17

No results posted yet for this study

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. The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. The primary objective of the study was to evaluate the safety and tolerability profile of Treamid after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination. The secondary objective of the study was to assess pharmacokinetics of active pharmaceutical substance of Treamid.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Treamid 5 mg

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

DRUG

Treamid 15 mg

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

DRUG

Treamid 50 mg

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

DRUG

Placebo

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Principal Investigators

  • Elena A Smolyarchuk, MD, PhD · The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-25
Primary Completion
2016-11-21
Completion
2016-11-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428593 on ClinicalTrials.gov