Trials Sponsors Conditions Drugs Pricing

Conditions

Bioequivalence Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total)
The maximum observed plasma concentration (Cmax)
At baseline and during 12 hours after product administration
The area under the plasma concentration-vs.-time curves from start of drug administration until the time of the last measurable concentration (AUCt) for paracetamol, guaifenesin and phenylephrine (total)
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for paracetamol, guaifenesin and phenylephrine (total)
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of paracetamol, guaifenesin and phenylephrine (total)
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until infinity
From 12 hours after start of drug administration until up to 96 hours

Secondary Outcomes (8)

Peak Plasma Concentration (Cmax) of unconjugated phenylephrine
At baseline and during 12 hours after product administration
The area under the plasma concentration-vs.-time curves from start of drug administration until the time of the last measurable concentration (AUCt) for unconjugated phenylephrine
At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for unconjugated phenylephrine
At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of unconjugated phenylephrine
From 12 hours after start of drug administration until up to 96 hours
The time at which the maximum plasma concentration is observed (tmax) for unconjugated phenylephrine
At baseline and during 12 hours after product administration

Study Arms (2)

Treatment sequence AB

EXPERIMENTAL

Treatment A (experimental): Two tablets of Combination tablet with paracetamol, guaifenesin and phenylephrine hydrochloride each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride Treatment B (active comparator): One sachet Vicks Active SymptoMax Plus, powder for oral solution, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride

Drug: Tablet paracetamol, guaifenesin and phenylephrine HCLDrug: Vicks Active SymptoMax Plus powder for oral solution

Treatment sequence BA

EXPERIMENTAL

Drug: Tablet paracetamol, guaifenesin and phenylephrine HCL

Interventions

Tablet paracetamol, guaifenesin and phenylephrine HCLDrug

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

Also known as: Benylin Cough & Cold All in One Relief Tablets

Treatment sequence ABTreatment sequence BA

Vicks Active SymptoMax Plus powder for oral solutionDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Tablet paracetamol, guaifenesin and phenylephrine HCL
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subjects being verified as "Healthy": "Healthy" is defined as absence of any diseases or abnormalities on the basis of physical examination, standard clinical laboratory, and instrumental examinations performed at the screening visit.
Females of childbearing potential must have a negative urine pregnancy test at the baseline visit.

Sponsors & Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide
Industrylead

Study Sites (1)

Scientific Research center Eco-Safety LLC

Saint Petersburg, 196143, Russia

MeSH Terms

Interventions

GuaifenesinOxymetazolinePowdersSolutions

Intervention Hierarchy (Ancestors)

GuaiacolMethyl EthersEthersOrganic ChemicalsPhenyl EthersCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

Elisabeth Kruse, PhD
McNeil AB
STUDY DIRECTOR

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

July 11, 2017

Study Start

July 3, 2017

Actual (reported)

You may not qualify if:

Use of medications, including prescription medication, over-the-counter medication including vitamins, herbal supplements, medicinal plants (e.g., supplements containing garlic extract), and topical preparations of drugs that are systemically absorbed (e.g., steroids and non-steroid anti-inflammatory drugs) within two weeks prior to dosing.
Use of St. John's wort (Hypericum perforatum) within 30 days prior to dosing.
Depot injection or an implant of any drug within 3 months prior to dosing.
Abnormal results of laboratory and instrumental methods of examinations, including electrocardiogram (ECG).
Is hypersensitive, intolerant, or has experienced an allergic reaction to the active ingredients or excipients of drug products that will be used for the study, or has had severe allergy (e.g., anaphylaxis, angioedema) in the past.
Females with a positive pregnancy test and/or are breast-feeding.
Females, currently using hormonal contraceptives (including use less than 2 months prior to enrollment).
Males with a pregnant spouse or partner or males who are not willing to prevent conception in a spouse or partner.
History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 10 alcohol units (2 L of wine or 5 L of beer or 0.5 L of spirits) or presence of information on alcoholism, substance, or drug abuse in medical history.
Alcohol consumption within 48 hours prior to dosing, positive respiratory alcohol test at screening, or inability to abstain from alcohol consumption until the last blood sample collection of each study period.
Volunteers who smoke more than 10 cigarettes per day or have an uncontrollable habit of chewing or inhaling nicotine products.
Drug addiction in history, or a positive urine test for psychoactive or narcotic substances.
Use of caffeine products exceeding 500 mg caffeine daily (5 cups of coffee) and the inability to abstain from caffeine products within 48 hours before dosing and prior to the last blood sample collection of each study period.
Use of xanthine containing products (e.g., coffee, tea, chocolate, or cola drink) within 48 hours before dosing and prior to the last blood sample collection of each study period.
Ingestion of food or beverages containing grapefruit, Chinese grapefruit (pomelo), or Seville oranges (including marmalade) within 10 days prior to the first dose of the investigational product and inability to stop taking these products during the study.
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (8)

Study Arms (2)

Treatment sequence AB

Treatment sequence BA

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (8)

Study Arms (2)

Treatment sequence AB

Treatment sequence BA

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations