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

NCT03213353 | Completed Phase 1

• 1 other identifier: CO-160408130708-URCT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

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

• The time at which the maximum plasma concentration is observed (tmax) for paracetamol, guaifenesin and phenylephrine (total)

  Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs

  At baseline and during 12 hours after product administration

• The half-life (t1/2) for paracetamol, guaifenesin and phenylephrine (total) in plasma

  The half-life i defined as the time taken for the plasma concentration to fall to half its original value

  At baseline and during 12 hours after product administration

• The terminal elimination rate constant (λz) for paracetamol, guaifenesin and phenylephrine (total) in plasma

  The terminal elimination rate constant is the rate at which the drug is removed from the body system

  At baseline and during 12 hours after product administration

• The mean residence time (MRT) for paracetamol, guaifenesin and phenylephrine (total)

  Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body

  At baseline and during 12 hours after product administration

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 HCL; Drug: Vicks Active SymptoMax Plus powder for oral solution

Treatment sequence BA

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 HCL; Drug: Vicks Active SymptoMax Plus powder for oral solution

Interventions

Tablet paracetamol, guaifenesin and phenylephrine HCL DRUG

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 AB; Treatment sequence BA

Vicks Active SymptoMax Plus powder for oral solution DRUG

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

Treatment sequence AB; Treatment sequence BA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• Body Mass Index (BMI) between 18.5 and 30.0 kg/m2, inclusive, and a total body weight of at least 50.0 kg.
• Volunteers who agree to abstain from alcohol consumption for at least 48 hours prior to dosing and until the last blood sample collection of each study period.

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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Scientific Research center Eco-Safety LLC

Saint Petersburg, 196143, Russia

Location

Related Links

• Redacted Study Synopsis

MeSH Terms

Interventions

Guaifenesin; Oxymetazoline; Powders; Solutions

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

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
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)