HealthyPhase 4NCT03029650
Scopolamine Patch Pharmacokinetics in Healthy Adults
A Phase 4 study testing Transderm Scop® and Intravenous scopolamine hydrobromide in people with Healthy, run by University of Iowa at 1 site in United States.
Trial summary
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transderm Scop® and Intravenous scopolamine hydrobromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women of any ethnic background between the age of 18 and 65 years old.
- Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and are not currently using tobacco products.
- Provide written informed consent before initiation of any study procedures.
- Available for follow-up for the planned duration of the study.
- Able to communicate well with the investigators.
- Able to adhere to the study protocol schedule, study restrictions and examination schedule.
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- Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
- Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
- Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
- Negative urine drug screening test.
- Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
- Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST, and total bilirubin.
- Have normal screening laboratories for urine protein and urine glucose.
- Female subjects must be of non-childbearing potential (defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year [no bleeding for 12 consecutive months]), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
- Agrees not to participate in another clinical study during the study period unless the study is in the follow up phase and it has been 1 month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 1 month after last procedure day.
- Agrees not to donate blood to a blood bank throughout participation in the study and for at least 2 months after last procedure day.
- Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block (sinus rhythm is between 55-100 beats per minute).
Who cannot join
- Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any procedure session.
- Smokers (current use or use over the previous 12 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)).
- Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow up phase and it has been ≥ 1 month since the subject received any experimental agents or treatments..
- Abnormal vital signs, defined as:
- Hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) at rest on 2 separate days.
- Heart rate <55 at rest on 2 separate days
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- Respiratory rate ≤ 11 to ≥ 18 breaths per minute
- Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the scopolamine TDDS.
- History of chronic obstructive pulmonary disease.
- Positive urine drug screening test.
- Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications not included).
- Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product (e.g. antihistamines [within 72 hours prior to dosing], systemic or topical corticosteroids [within 3 weeks prior to dosing], cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, radiation therapy).
- Donation or loss of greater than one pint of blood within 60 days of entry to the study.
- Any prior serious adverse reaction or hypersensitivity to scopolamine, or any of the inactive ingredients in the TDDS (light mineral oil, polyisobutylene, polypropylene and aluminized polyester film).
- Have a diagnosis of schizophrenia or other major psychiatric diagnosis.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
- Medical history of a serious chronic condition, including (but not limited to): allergic conditions such as anaphylaxis, asthma or generalized drug reactions; any seizure disorder; glaucoma (open or closed angle); history of pyloric or urinary bladder neck obstruction; intestinal obstruction; difficulty swallowing; stomach or bowel problems (e.g, blockage, muscle weakness, ulcerative colitis, Crohn's disease); bleeding disorders; acid reflux disease; myasthenia gravis; allergy to belladonna alkaloids; impaired hepatic or renal function.
- Any condition that would, in the opinion of the MAI, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Inability to communicate or co-operate with the investigators.
- Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).
- History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.
- History of consumption of alcohol within 24 hours prior to dose administration.
- Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site, sunburn, raised moles and scars, open sores at application site, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug.
- Use of monoamine oxidase inhibitors 21 days prior to study.
- Within 4 weeks prior to dosing, use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product or agents deemed to be immunosuppressive as determined by physician investigator.
- Planned MRI scan of the head during TDDS wear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of the Transderm Scōp System in Healthy Adults
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
Read the detailed description
Transdermal drug delivery systems (TDDS) available in the form of patches are convenient, attractive, and easy to use systems. Scopolamine patches are very popular TDDS available on the United States market today. Accurate determination of the rate and extent of drug release and absorption is crucial to ensure the safety of individuals using these and other types of patches. Delivery rate can be determined early in the development process by using in vitro skin flux permeation studies, and later in humans by accurately quantifying residual drug from patches post-wear and in pharmacokinetic studies. In this proposal, the investigators will employ two types of evaluation to determine the rate and extent of drug release and absorption from RLD (reference listed drug) Transderm Scop® TDDS (transdermal drug delivery system), namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult volunteers. In addition, the investigators will compare the plasma drug concentrations following patch and intravenous administration of Scopolamine, in order to determine the absolute bioavailability of these patches. The investigators will conduct residual drug analysis of TDDS following in vivo wear using highly sensitive validated quantification methods. Positive outcomes of this project will identify appropriate methods to determine the rate and extent of drug release and absorption from TDDS, and will help regulatory agencies in the development of Guidances for Industry regarding the characterization of drug release and absorption kinetics to ensure the safety of individuals utilizing these types of products
- Conditions
- Healthy
- Being tested
- Transderm Scop®, Intravenous scopolamine hydrobromide
- Keywords
- Peer Review, Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transderm Scop®Drug
TDDS dosage is 1.5 mg/72 hrs
Intravenous scopolamine hydrobromideDrug
0.4 mg via intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Transderm Scop® | Active comparator | Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®). Receives: Drug: Transderm Scop®; Drug: Intravenous scopolamine hydrobromide |
| Intravenous scopolamine hydrobromide | Experimental | Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®). Receives: Drug: Transderm Scop®; Drug: Intravenous scopolamine hydrobromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Maximum Serum Concentration of Scopolamine (Cmax)
Measured: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Secondary outcomes (6)
Assessment of Scopolamine Clearance (CL)
This will be done only after the IV is administered to estimate the rate of removal of scopolamine from the body. Will not be measured during patch arm.
Measured: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr
Measurement of Volume of Scopolamine Distribution (V)
This measure is only analyzed for the IV scopolamine HBr arm of the study.
Measured: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr
Measurement of Elimination Rate Constant of Scopolamine (Kel)
Measured: Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)
Measured: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Determination of Area Under the Serum Concentration-time Curve (AUC)
Measured: Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr
Residual Drug Analysis in Worn TDDS
This will be done in the TDDS after its removal to estimate total amount of absorbed scopolamine.
Measured: 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Nicole K Brogden, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029650
- Sponsor's protocol ID
- 201506778
- Status last verified
- Jun 2018
- First submitted
- 17 Jan 2017
- Last updated
- 21 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of the Transderm Scōp System in Healthy Adults
- ClinicalTrials.gov ID
- NCT03029650
- Acronym / sponsor ID
- 201506778
- Conditions
- Healthy
- Keywords
- Peer Review, Research
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 21 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
Detailed description
Transdermal drug delivery systems (TDDS) available in the form of patches are convenient, attractive, and easy to use systems. Scopolamine patches are very popular TDDS available on the United States market today. Accurate determination of the rate and extent of drug release and absorption is crucial to ensure the safety of individuals using these and other types of patches. Delivery rate can be determined early in the development process by using in vitro skin flux permeation studies, and later in humans by accurately quantifying residual drug from patches post-wear and in pharmacokinetic studies. In this proposal, the investigators will employ two types of evaluation to determine the rate and extent of drug release and absorption from RLD (reference listed drug) Transderm Scop® TDDS (transdermal drug delivery system), namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult volunteers. In addition, the investigators will compare the plasma drug concentrations following patch and intravenous administration of Scopolamine, in order to determine the absolute bioavailability of these patches. The investigators will conduct residual drug analysis of TDDS following in vivo wear using highly sensitive validated quantification methods. Positive outcomes of this project will identify appropriate methods to determine the rate and extent of drug release and absorption from TDDS, and will help regulatory agencies in the development of Guidances for Industry regarding the characterization of drug release and absorption kinetics to ensure the safety of individuals utilizing these types of products
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transderm Scop® | Active comparator | Drug: Transderm Scop®, Drug: Intravenous scopolamine hydrobromideEach of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®). |
| Intravenous scopolamine hydrobromide | Experimental | Drug: Transderm Scop®, Drug: Intravenous scopolamine hydrobromideEach of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men or non-pregnant women of any ethnic background between the age of 18 and 65 years old.
- Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and are not currently using tobacco products.
- Provide written informed consent before initiation of any study procedures.
- Available for follow-up for the planned duration of the study.
- Able to communicate well with the investigators.
Key exclusion criteria (26 listed)
- Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any procedure session.
- Smokers (current use or use over the previous 12 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)).
- Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow up phase and it has been ≥ 1 month since the subject received any experimental agents or treatments..
- Abnormal vital signs, defined as:
- Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the scopolamine TDDS.
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 |
|---|---|---|
| Transderm Scop®TDDS dosage is 1.5 mg/72 hrs | Drug | Intravenous scopolamine hydrobromide, Transderm Scop® |
| Intravenous scopolamine hydrobromide0.4 mg via intravenous injection | Drug | Intravenous scopolamine hydrobromide, Transderm Scop® |
Primary outcome
Measurement of Maximum Serum Concentration of Scopolamine (Cmax)
Time frame: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
6 secondary outcomes
Assessment of Scopolamine Clearance (CL)
Time frame: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr
Measurement of Volume of Scopolamine Distribution (V)
Time frame: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr
Measurement of Elimination Rate Constant of Scopolamine (Kel)
Time frame: Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)
Time frame: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Determination of Area Under the Serum Concentration-time Curve (AUC)
Time frame: Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr
Residual Drug Analysis in Worn TDDS
Time frame: 3 - 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transderm Scop® and Intravenous scopolamine hydrobromide in people with Healthy, run by University of Iowa at 1 site in United States.
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 17 inclusion and 26 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 21 Jun 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Maximum Serum Concentration of Scopolamine (Cmax) (time frame: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.