BioequivalencePhase 1NCT03213353

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

A Phase 1 study testing Tablet paracetamol, guaifenesin and phenylephrine HCL and Vicks Active SymptoMax Plus powder for oral solution in people with Bioequivalence and Healthy Volunteers, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence, Healthy Volunteers
What is being tested?: Tablet paracetamol, guaifenesin and phenylephrine HCL and Vicks Active SymptoMax Plus powder for oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteRussia
Study dates: 3 Jul 2017to 17 Jul 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.
Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partner's use of a highly effective method of birth control for at least 3 months before the study, during the study, and for 30 days after the last dose of study drug) as outlined in Section 11.6 (Note: Female subjects are not permitted to use hormonal contraceptives as per exclusion criterion 7).
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.

Who cannot join

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.

Show all 21Show fewer

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.
Positive test for human immunodeficiency virus (HIV) 1 or 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (RW).
Heart rate <60 or >90 per minute at rest, or systolic blood pressure <100 or >130 mm Hg, or diastolic blood pressure <70 or >90 mm Hg.
Clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, eye, ear, nose and throat disease, liver disorders, severe chronic kidney disease, active gastric or duodenal ulcer, benign prostate hyperplasia, phenylketonuria, hypertension, hyperthyroidism, diabetes, heart disease, aortic stenosis, tachyarrhythmia, glaucoma or phaeochromocytoma.
Hereditary problems of glucose-galactose malabsorption, fructose intolerance, or sucrose/isomaltase deficiency.
History of gastrointestinal surgery other than appendectomy.
Medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Scientific Research center Eco-Safety LLC
Saint Petersburg, 196143

Other trials in Russia

About this study

Official title: A SingleDose Rand, TwoPeriod, Crossover Bioequivalence Study Between a Combination Tablet With Paracetamol, Guaifenesin and Penylephrine HCL (Wrafton Lab Ltd, UK) and Vicks Active SymptoMax Plus, Powder for Oral Solution (Wrafton Lab Ltd, UK) in Healthy Adult Volunteers

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
Being tested: Tablet paracetamol, guaifenesin and phenylephrine HCL, Vicks Active SymptoMax Plus powder for oral solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tablet paracetamol, guaifenesin and phenylephrine HCLDrug
Also called Benylin Cough & Cold All in One Relief Tablets
Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride
Vicks Active SymptoMax Plus powder for oral solutionDrug
Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride

Study groups in NCT03213353
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Tablet paracetamol, guaifenesin and phenylephrine HCL; Drug: Vicks Active SymptoMax Plus powder for oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total)
The maximum observed plasma concentration (Cmax)
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and during 12 hours after product administration

Secondary outcomes (8)

Peak Plasma Concentration (Cmax) of unconjugated phenylephrine
The maximum observed plasma concentration (Cmax)
Measured: 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
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Measured: At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for unconjugated phenylephrine
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
Measured: At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of unconjugated phenylephrine
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until the plasma concentration is negligible (infinity).
Measured: 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
Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs
Measured: At baseline and during 12 hours after product administration
The half-life (t1/2) for unconjugated phenylephrine in plasma
The half-life i defined as the time taken for the plasma concentration to fall to half its original value
Measured: At baseline and during 12 hours after product administration
The terminal elimination rate constant (λz) for unconjugated phenylephrine in plasma
The terminal elimination rate constant is the rate at which the drug is removed from the body system
Measured: At baseline and during 12 hours after product administration
The mean residence time (MRT) for unconjugated phenylephrine
Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body
Measured: At baseline and during 12 hours after product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201717 Jul 2017

First posted11 Jul 2017
Study start3 Jul 2017
Primary completion17 Jul 2017
Study completion17 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BioequivalenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03213353
Sponsor's protocol ID: CO-160408130708-URCT
Status last verified: Jul 2018
First submitted: 20 Jun 2017
Last updated: 6 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A SingleDose Rand, TwoPeriod, Crossover Bioequivalence Study Between a Combination Tablet With Paracetamol, Guaifenesin and Penylephrine HCL (Wrafton Lab Ltd, UK) and Vicks Active SymptoMax Plus, Powder for Oral Solution (Wrafton Lab Ltd, UK) in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT03213353
Acronym / sponsor ID: CO-160408130708-URCT
Conditions: Bioequivalence, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
Study start: 3 Jul 2017 (actual)
Primary completion: 17 Jul 2017 (actual)
Study completion: 17 Jul 2017 (actual)
First posted: 11 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment sequence AB	Experimental	Drug: Tablet paracetamol, guaifenesin and phenylephrine HCL, Drug: Vicks Active SymptoMax Plus powder for oral solutionTreatment 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
Treatment sequence BA	Experimental	Drug: Tablet paracetamol, guaifenesin and phenylephrine HCL, Drug: Vicks Active SymptoMax Plus powder for oral solutionTreatment 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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.
Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partner's use of a highly effective method of birth control for at least 3 months before the study, during the study, and for 30 days after the last dose of study drug) as outlined in Section 11.6 (Note: Female subjects are not permitted to use hormonal contraceptives as per exclusion criterion 7).
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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tablet paracetamol, guaifenesin and phenylephrine HCLAlso: Benylin Cough & Cold All in One Relief TabletsEach subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride	Drug	Treatment sequence AB, Treatment sequence BA
Vicks Active SymptoMax Plus powder for oral solutionEach subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride	Drug	Treatment sequence AB, Treatment sequence BA

Primary outcome

Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total)
Time frame: At baseline and during 12 hours after product administration
The maximum observed plasma concentration (Cmax)
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)
Time frame: At baseline and during 12 hours after product administration
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for paracetamol, guaifenesin and phenylephrine (total)
Time frame: At baseline and during 12 hours after product administration
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the plasma concentration is negligible (infinity).
The extrapolated part of AUC∞, AUCExtrap of paracetamol, guaifenesin and phenylephrine (total)
Time frame: From 12 hours after start of drug administration until up to 96 hours
AUCextrap is defined as area under the plasma concentration versus time curves from 12 hours until infinity
The time at which the maximum plasma concentration is observed (tmax) for paracetamol, guaifenesin and phenylephrine (total)
Time frame: At baseline and during 12 hours after product administration
Tmax is defined as the time point at which the maximum plasma concentration (Cmax) occurs
The half-life (t1/2) for paracetamol, guaifenesin and phenylephrine (total) in plasma
Time frame: At baseline and during 12 hours after product administration
The half-life i defined as the time taken for the plasma concentration to fall to half its original value
The terminal elimination rate constant (λz) for paracetamol, guaifenesin and phenylephrine (total) in plasma
Time frame: At baseline and during 12 hours after product administration
The terminal elimination rate constant is the rate at which the drug is removed from the body system
The mean residence time (MRT) for paracetamol, guaifenesin and phenylephrine (total)
Time frame: At baseline and during 12 hours after product administration
Mean residence time (MRT) is the average amount of time that a single molecule of drug stays in the body

8 secondary outcomes

Peak Plasma Concentration (Cmax) of unconjugated phenylephrine
Time frame: 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
Time frame: At baseline and during 12 hours after product administration
The area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) for unconjugated phenylephrine
Time frame: At baseline and during 12 hours after product administration
The extrapolated part of AUC∞, AUCExtrap of unconjugated phenylephrine
Time frame: 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
Time frame: At baseline and during 12 hours after product administration
The half-life (t1/2) for unconjugated phenylephrine in plasma
Time frame: At baseline and during 12 hours after product administration
The terminal elimination rate constant (λz) for unconjugated phenylephrine in plasma
Time frame: At baseline and during 12 hours after product administration
The mean residence time (MRT) for unconjugated phenylephrine
Time frame: At baseline and during 12 hours after product administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
Redacted Study SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Bioequivalence

Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elisabeth Kruse, PhD study director

McNeil AB

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) of paracetamol, guaifenesin and phenylephrine (total) (time frame: At baseline and during 12 hours after product administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03213353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.