HealthyPhase 1NCT05182047

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

A Phase 1 study testing Butamirate citrate and Sinecod in people with Healthy, run by McNeil AB at 1 site in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Butamirate citrate and Sinecod
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteRussia
Study dates: 18 Mar 2022to 5 May 2022
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

Male and/or female volunteers between the ages of 18 and 45 years, inclusive, with verified diagnosis of healthy: the absence of any gastrointestinal, liver, kidney, cardiovascular, neurologic and infectious or respiratory disease (with no abnormalities as judged by standard clinical, laboratory and instrumental investigations)
Non- or ex-tobacco users, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 12 months before first dose of the study drug in this study
Volunteers will have a Body Mass Index (BMI) between 18.5 to 30 kilograms per meter square (kg/m^2), inclusive, and a total body weight greater than (>) 50 kg
For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum follicle-stimulating hormone [FSH] level exceeding 30 international units per liter [IU/L]) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, or transdermal hormonal contraceptives, vaginal contraceptive ring, intrauterine device or status after operative sterilization), during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse during the study and 30 days thereafter
For males: No pregnant spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and 30 days thereafter
A personally signed and dated informed consent document, indicating that the volunteer has been informed of all pertinent aspects of the study
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol

Who cannot join

Hypersensitivity to the ingredients/components of any of the investigational products and/or fructose intolerance
Burdened history of allergy
Special diet (that is, vegetarian or vegan diet, salt-restricted diet) or life style (working night shifts, extreme physical exercise)
Regular (that is, more than once administration) use of any nonprescription or prescription medications other than contraceptives specified in Inclusion criteria #4, within 2 weeks prior to screening
Use of any nonprescription or prescription medications, profoundly influencing hemodynamics, liver function, Et cetera (etc.) (barbiturates, omeprazole, cimetidine, etc.) within 30 days prior to screening
Use of any vitamins, dietary and herbal supplements within 14 days prior to screening

Show all 29Show fewer

Depot injection or an implant of any drug other than contraceptives specified in Inclusion criteria #4 within 3 months prior to screening
Females: Confirmed pregnancy or a positive pregnancy test at the screening visit or planning to become pregnant during the duration of the study, and/or breastfeeding
History of gastrointestinal surgery other than appendectomy
Cardiovascular, respiratory, neuroendocrine diseases, as well as gastrointestinal, liver, kidney or hematologic disorders
Positive test for human immunodeficiency virus (HIV) 1 or 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (WR)
Acute infectious disease within 4 weeks prior to screening
Positive nasal or oropharyngeal polymerase chain reaction (PCR) test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) ribonucleic acid (RNA)
Risk or confirmed SARS-CoV-2 infection (Coronavirus disease 2019 [COVID-19]): a. History of a confirmed or suspected COVID-19 infection in the last 30 days; b. Contact with COVID-19-infected person within 14 days prior to screening or Visit 2; c. Any international travel within 14 days including members in the same household prior to screening or Visit 2; d. Participants with self-reported symptoms within the past 2 weeks prior to screening or Visit 2: i. Unexplained cough, shortness/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; ii. Body temperature greater than or equal to (>=) 37.5 degree Celsius (°C), measured in axillar area; iii. Or who have used fever or pain reducers within past 2 days of each onsite visit
Preplanned vaccination within 5 days prior to dosing. (Regarding study visit scheduling: every effort should be made to ensure volunteers receive necessary vaccinations without delay)
Alcohol consumption that exceeds weekly limits of 10 alcohol units (1 unit is equivalent to 500 milliliters (mL) of beer or 200 mL of wine or 50 mL of spirits) or history of alcoholism
Consumed alcohol beverage(s) within 48 hours prior to the first scheduled dose of the study drug, positive urine alcohol test at screening, or inability to abstain from alcohol consumption during the entire study period
History of narcotic substance and/or drug dependence and/or toxicomania and/or drug abuse
Positive urine screen for narcotic substance abuse
Use of xanthine containing products (example, coffee, tea, chocolate or cola drink) within 48 hours before each dose of study drug
Ingestion of food or beverages containing grapefruit, Chinese grapefruit (pomelo) or Seville oranges (including marmalade) within 10 days before the first dose of study drug and throughout the study
Participation in clinical trials of medicinal products within 90 days prior to screening
Donation or loss of blood within 3 months prior to the first dose of study drug if the estimated lost blood volume equaled or exceeded 450 mL
Abnormal results of laboratory and instrumental methods of examinations, including electrocardiogram (ECG) at screening
Heart rate less than (<) 60 or greater than (>) 90 per minute at rest, or systolic blood pressure <100 or >130 millimeter of mercury (mm Hg), or diastolic blood pressure <70 or >90 mm Hg measured at screening visit
Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study
Any acute or chronic, medical or psychiatric condition(s) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified investigator, would make the volunteer inappropriate for entry into this study
Any psychologic, emotional problems, and any other condition(s) that may interfere with signing of informed consent form or complying with protocol requirements, for example, inability to adequately cooperate with study personnel
Relationship to persons involved directly with the conduct of the study (that is, principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson [J\&J] subsidiaries; and the families of each)

Trial locations and contacts

1 site in 1 country.

Russia1 site

"Scientific and Research centre Eco-safety" Limited Liability Company, 65, Yuri Gagarin prospect
Saint Petersburg, 196143

Other trials in Russia

About this study

Official title: A Randomized, Open, Crossover, Single Dose, Bioequivalence Study of a Novel Medication Butamirate Citrate Syrup 1.5 mg/mL (McNeil Iberica S.L.U., Spain) vs. Sinecod Syrup (Vanilla) 1.5 mg/mL (GSK Consumer Healthcare S.A., Switzerland), in Adult Healthy Study Volunteers

Conditions: Healthy
Being tested: Butamirate citrate, Sinecod

What participants receive

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

Butamirate citrateDrug
Butamirate citrate syrup will be administered orally.
SinecodDrug
Sinecod syrup will be administered orally.

Study groups in NCT05182047
Study group	Role	What they receive
Treatment Sequence AB	Experimental	Participant will receive a single oral dose of butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL) (Treatment A [investigational product]) on Day 1 in Treatment Period 1, followed by a single oral dose of sinecod syrup (vanilla) 1.5 mg/mL (Treatment B [Reference product]) on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period. Receives: Drug: Butamirate citrate; Drug: Sinecod
Treatment Sequence BA	Experimental	Participants will receive Treatment B on Day 1 in Treatment Period 1, followed by Treatment A on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period. Receives: Drug: Butamirate citrate; Drug: Sinecod

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of 2-phenylbuturic Acid
Cmax is defined as the maximum observed plasma concentration of 2-phenylbuturic acid.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose
Area Under the Concentration Versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable 2-phenylbuturic Acid Plasma Concentration (AUC [tau])
AUC (tau) is defined as the area under the concentration versus time curve from start of drug administration until the time of the last measurable 2-phenylbuturic acid plasma concentration.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose

Secondary outcomes (10)

Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC [infinity]) of 2-phenylbuturic Acid
AUC (infinity) is defined as the area under the concentration versus time curve extrapolated to infinity of 2-phenylbuturic acid.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Extrapolated part of Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUCextrap) of 2-phenylbuturic Acid
AUCextrap is defined as extrapolated part of AUC (infinity) of 2-phenylbuturic acid.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Time at Which the Maximum Plasma Concentration of 2-phenylbuturic Acid is Observed (Tmax)
Tmax is defined as the time at which the maximum plasma concentration of 2-phenylbuturic acid is observed.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Rate Constant (lambda[z]) for 2-phenylbuturic Acid in Plasma
Lambda(z) is defined as the rate at which the 2-phenylbuturic acid is removed from the body system.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Half-life (t1/2) of 2-phenylbuturic Acid in Plasma
T1/2 is defined as the time it takes for the 2-phenylbuturic acid plasma concentration to reduce to half of its original value.
Measured: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Measured: Up to 29 days
Number of Participants with AEs by Severity
Number of participants with AEs by severity will be reported. The severity of AEs will be assessed by the medically qualified Investigator or designee using the following general categorical descriptors: a) Mild: awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with the volunteer's usual function or normal everyday activities; b) Moderate: sufficient discomfort is present to cause interference to some extent with the volunteer's usual function or normal everyday activity; c) Severe: extreme distress, causing significant impairment of functioning or incapacitation; interferes significantly with volunteer's usual function; prevents normal everyday activities.
Measured: Up to 29 days
Number of Participants with AE Relationship to Investigational Product Assessment
Number of participants with AE relationship to investigational product assessment will be reported.
Measured: Up to 29 days
Number of Participants with Change from Baseline in Vital Signs Parameters
Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, and blood pressure) will be reported.
Measured: Up to 29 days
Number of Participants with Change from Baseline in Safety Laboratory Parameters
Number of participants with change from baseline in safety laboratory parameters (including physical examination, clinical laboratory tests and electrocardiograms [ECG]) will be reported.
Measured: Up to 29 days

Timeline

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

18 Mar 20225 May 2022

First posted10 Jan 2022
Study start18 Mar 2022 (estimated)
Primary completion5 May 2022 (estimated)
Study completion5 May 2022 (estimated)

Why it stopped: Business decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05182047
Sponsor's protocol ID: CCSURA001534
Other IDs: CCSURA001534
Status last verified: May 2022
First submitted: 20 Dec 2021
Last updated: 20 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

Bohner H, Janiak PS, Nitsche V, Eichinger A, Schutz H. Relative bioavailability of different butamirate citrate preparations after single dose oral administration to 18 healthy volunteers. Int J Clin Pharmacol Ther. 1997 Mar;35(3):117-22.
PubMed 9089001
Faruqi S, Wright C, Thompson R, Morice AH. A randomized placebo controlled trial to evaluate the effects of butamirate and dextromethorphan on capsaicin induced cough in healthy volunteers. Br J Clin Pharmacol. 2014 Dec;78(6):1272-80. doi: 10.1111/bcp.12458.
PubMed 24995954
Miko P. [The use and safety of butamirate containing drops, syrup and depot tablets in Hungary]. Orv Hetil. 2005 Mar 27;146(13):609-12. Hungarian.
PubMed 15856625
Berthelot, J. and M.-A. Weibel, Comparative Clinical Evaluation of the Antitussive Activity of Butamirate Citrate Linctus (Sinecod) v. a Codeinecontaining linctus (Netux). Clinical trials journal, 1990. 27(1).
Germouty J, Weibel MA. [Clinical comparison of butamirate citrate with a codeine-based antitussive agent]. Rev Med Suisse Romande. 1990 Nov;110(11):983-6. No abstract available. French.
PubMed 1980027
Lejeune J, Weibel MA. [Comparison of 2 antitussive agents in pediatrics (butamirate citrate in drinkable solution and zipeprol syrup)]. Rev Med Suisse Romande. 1990 Feb;110(2):181-5. No abstract available. French.
PubMed 2315598
Charpin J, Weibel MA. Comparative evaluation of the antitussive activity of butamirate citrate linctus versus clobutinol syrup. Respiration. 1990;57(4):275-9. doi: 10.1159/000195855.
PubMed 2095610
Materazzi, F., et al., Note terapeutiche sul butamirato citrato. Gazzetta Medica Italiana - Archivio Scienze Mediche, 1984(143): p. 229-232
EMEA Guideline on the Investigation of Bioequivalence, January 2010, CPMP/EWP/QWP/1401/98
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714
Manual on medicinal products evaluation (in Russian), V.1 (1), 2013. 328 с. FSBI "Scientific Centre for Expert Evaluation of Medicinal Products", Ministry of Health and Family Welfare of the Russian Federation.
Resolution # 85 of CEEC "On the Rules for conducting bioequivalence studies of drug products on the territory of EAEU" dated 3-Nov-2016
APPENDIX #6 to the "Rules for conducting bioequivalence studies of drug products on the territory of EAEU" dated 3-Nov-2016
EMA Guideline on Bioanalytical Method Validation, EMEA/CHMP/EWP/192217/2009
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
PubMed 11381568

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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open, Crossover, Single Dose, Bioequivalence Study of a Novel Medication Butamirate Citrate Syrup 1.5 mg/mL (McNeil Iberica S.L.U., Spain) vs. Sinecod Syrup (Vanilla) 1.5 mg/mL (GSK Consumer Healthcare S.A., Switzerland), in Adult Healthy Study Volunteers
ClinicalTrials.gov ID: NCT05182047
Acronym / sponsor ID: CCSURA001534
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Business decision.
Enrolment: 0 participants (actual)
Lead sponsor: McNeil ABIndustry (pharma, biotech, devices)
Study start: 18 Mar 2022 (estimated)
Primary completion: 5 May 2022 (estimated)
Study completion: 5 May 2022 (estimated)
First posted: 10 Jan 2022 (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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Sequence AB	Experimental	Drug: Butamirate citrate, Drug: SinecodParticipant will receive a single oral dose of butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL) (Treatment A [investigational product]) on Day 1 in Treatment Period 1, followed by a single oral dose of sinecod syrup (vanilla) 1.5 mg/mL (Treatment B [Reference product]) on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period.
Treatment Sequence BA	Experimental	Drug: Butamirate citrate, Drug: SinecodParticipants will receive Treatment B on Day 1 in Treatment Period 1, followed by Treatment A on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period.

Who may qualify

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

Key inclusion criteria (7 listed)

Male and/or female volunteers between the ages of 18 and 45 years, inclusive, with verified diagnosis of healthy: the absence of any gastrointestinal, liver, kidney, cardiovascular, neurologic and infectious or respiratory disease (with no abnormalities as judged by standard clinical, laboratory and instrumental investigations)
Non- or ex-tobacco users, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 12 months before first dose of the study drug in this study
Volunteers will have a Body Mass Index (BMI) between 18.5 to 30 kilograms per meter square (kg/m^2), inclusive, and a total body weight greater than (>) 50 kg
For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum follicle-stimulating hormone [FSH] level exceeding 30 international units per liter [IU/L]) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, or transdermal hormonal contraceptives, vaginal contraceptive ring, intrauterine device or status after operative sterilization), during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse during the study and 30 days thereafter
For males: No pregnant spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and 30 days thereafter

Key exclusion criteria (29 listed)

Hypersensitivity to the ingredients/components of any of the investigational products and/or fructose intolerance
Burdened history of allergy
Special diet (that is, vegetarian or vegan diet, salt-restricted diet) or life style (working night shifts, extreme physical exercise)
Regular (that is, more than once administration) use of any nonprescription or prescription medications other than contraceptives specified in Inclusion criteria #4, within 2 weeks prior to screening
Use of any nonprescription or prescription medications, profoundly influencing hemodynamics, liver function, Et cetera (etc.) (barbiturates, omeprazole, cimetidine, etc.) within 30 days prior to screening

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
Butamirate citrateButamirate citrate syrup will be administered orally.	Drug	Treatment Sequence AB, Treatment Sequence BA
SinecodSinecod syrup will be administered orally.	Drug	Treatment Sequence AB, Treatment Sequence BA

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of 2-phenylbuturic Acid
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose
Cmax is defined as the maximum observed plasma concentration of 2-phenylbuturic acid.
Area Under the Concentration Versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable 2-phenylbuturic Acid Plasma Concentration (AUC [tau])
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose
AUC (tau) is defined as the area under the concentration versus time curve from start of drug administration until the time of the last measurable 2-phenylbuturic acid plasma concentration.

10 secondary outcomes

Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC [infinity]) of 2-phenylbuturic Acid
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Extrapolated part of Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUCextrap) of 2-phenylbuturic Acid
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Time at Which the Maximum Plasma Concentration of 2-phenylbuturic Acid is Observed (Tmax)
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Rate Constant (lambda[z]) for 2-phenylbuturic Acid in Plasma
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Half-life (t1/2) of 2-phenylbuturic Acid in Plasma
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Number of Participants With Adverse Events (AEs)
Time frame: Up to 29 days
Number of Participants with AEs by Severity
Time frame: Up to 29 days
Number of Participants with AE Relationship to Investigational Product Assessment
Time frame: Up to 29 days
Number of Participants with Change from Baseline in Vital Signs Parameters
Time frame: Up to 29 days
Number of Participants with Change from Baseline in Safety Laboratory Parameters
Time frame: Up to 29 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Background: PubMed 9089001Bohner H, Janiak PS, Nitsche V, Eichinger A, Schutz H. Relative bioavailability of different butamirate citrate preparations after single dose oral administration to 18 healthy volunteers. Int J Clin Pharmacol Ther. 1997 Mar;35(3):117-22.
Background: PubMed 24995954Faruqi S, Wright C, Thompson R, Morice AH. A randomized placebo controlled trial to evaluate the effects of butamirate and dextromethorphan on capsaicin induced cough in healthy volunteers. Br J Clin Pharmacol. 2014 Dec;78(6):1272-80. doi: 10.1111/bcp.12458.
Background: PubMed 15856625Miko P. [The use and safety of butamirate containing drops, syrup and depot tablets in Hungary]. Orv Hetil. 2005 Mar 27;146(13):609-12. Hungarian.
BackgroundBerthelot, J. and M.-A. Weibel, Comparative Clinical Evaluation of the Antitussive Activity of Butamirate Citrate Linctus (Sinecod) v. a Codeinecontaining linctus (Netux). Clinical trials journal, 1990. 27(1).
Background: PubMed 1980027Germouty J, Weibel MA. [Clinical comparison of butamirate citrate with a codeine-based antitussive agent]. Rev Med Suisse Romande. 1990 Nov;110(11):983-6. No abstract available. French.
Background: PubMed 2315598Lejeune J, Weibel MA. [Comparison of 2 antitussive agents in pediatrics (butamirate citrate in drinkable solution and zipeprol syrup)]. Rev Med Suisse Romande. 1990 Feb;110(2):181-5. No abstract available. French.
Background: PubMed 2095610Charpin J, Weibel MA. Comparative evaluation of the antitussive activity of butamirate citrate linctus versus clobutinol syrup. Respiration. 1990;57(4):275-9. doi: 10.1159/000195855.
BackgroundMaterazzi, F., et al., Note terapeutiche sul butamirato citrato. Gazzetta Medica Italiana - Archivio Scienze Mediche, 1984(143): p. 229-232
BackgroundEMEA Guideline on the Investigation of Bioequivalence, January 2010, CPMP/EWP/QWP/1401/98
Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
BackgroundManual on medicinal products evaluation (in Russian), V.1 (1), 2013. 328 с. FSBI "Scientific Centre for Expert Evaluation of Medicinal Products", Ministry of Health and Family Welfare of the Russian Federation.
BackgroundResolution # 85 of CEEC "On the Rules for conducting bioequivalence studies of drug products on the territory of EAEU" dated 3-Nov-2016
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

Konstantin A Zakharov, MD principal investigator

"Scientific and Research centre Eco-safety" Limited Liability Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Butamirate citrate and Sinecod in people with Healthy, run by McNeil AB at 1 site in Russia.

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 7 inclusion and 29 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: withdrawn, as of the sponsor's last update on 20 May 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Maximum Observed Plasma Concentration (Cmax) of 2-phenylbuturic Acid (time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose). The study lists 2 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 NCT05182047, which also lists 15 linked publications.

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 20 May 2022.