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A Study of Pharmacokinetics, Safety and Tolerability of Dimolegin (DD217)

NCT05181241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-01-06

No results posted yet for this study

Summary

In the course of the clinical study, the pharmacokinetics, pharmacodynamics, safety and tolerability of Dimolegin (DD217) 10 mg enteric-coated tablets after single administration to healthy volunteers at increasing doses were studied.

24 volunteers participated in the study. The randomization procedure was carried out for 24 volunteers selected at screening. In Group 1 6 volunteers were randomized , in Group 2 6 volunteers were randomized, and in Group 3 12 volunteers were enrolled. Group 1 volunteers took the study drug at a dose of 20 mg once, group 2 volunteers took the study drug at a dose of 40 mg once, and group 3 volunteers took the study drug at a dose of 60 mg once.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Dimolegin

Dimolegin (DD217) - enteric coated tablets 10 mg developed by PharmaDiall Ltd (Moscow), manufactured by Federal State Unitary Enterprise Research and Practical Center "Pharmaceutical Protection" at The Federal Medical Biological Agency (FMBA) of Russia

Sponsors & Collaborators

  • PharmaDiall Ltd.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2017-12-25
Completion
2018-04-25

Countries

  • Russia

Study Locations

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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 NCT05181241 on ClinicalTrials.gov