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A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms

NCT03213353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-07-06

No results posted yet for this study

Summary

This is a single-dose, randomized, two-period cross-over study with 72 healthy male and female volunteers. The investigational products will be given (after fasting overnight) at separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4, 5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture any adverse events that may occur. Bioequivalence will be assessed based on the single-dose pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively

Conditions

  • Bioequivalence
  • Healthy Volunteers

Interventions

DRUG

Tablet paracetamol, guaifenesin and phenylephrine HCL

Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride

DRUG

Vicks Active SymptoMax Plus powder for oral solution

Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2017-07-17
Completion
2017-07-17

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 NCT03213353 on ClinicalTrials.gov