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A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers

NCT05182047 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-05-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate bioequivalence with respect to rate and extent of absorption of 2-phenylbuturic acid of the novel medication butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL), and the medication sinecod syrup (vanilla) 1.5 mg/mL after single-dose administration in fasting condition by healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

Butamirate citrate

Butamirate citrate syrup will be administered orally.

DRUG

Sinecod

Sinecod syrup will be administered orally.

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Konstantin A Zakharov, MD · "Scientific and Research centre Eco-safety" Limited Liability Company

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2022-05-05
Completion
2022-05-05

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 NCT05182047 on ClinicalTrials.gov