Single Dose, Two-stage Bioequivalence Study of SCMC-Lys Salt 1.35 g Powder vs SCMC-Lys Salt 90 mg/mL Syrup

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02858193
Recruitment Status : Unknown
Verified July 2016 by Dompé Farmaceutici S.p.A.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Cross Research S.A.
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief Summary:
To investigate the bioequivalence between two formulations containing S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys) when administered as single oral dose in two consecutive study periods to healthy male and female volunteers under fasting conditions.

Condition or disease Intervention/treatment Phase
Bronchitis Drug: 1.35 g SCMC- lys powder Drug: Fluifort® syrup Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-way Crossover, Randomised, Single Dose and Two-stage Bioequivalence Phase I Study of Carbocysteine-L-lysine Salt 1.35 g Powder for Oral Solution Formulation Versus Carbocysteine-L-lysine Salt 90 mg/mL Syrup Formulation After Oral Administration to Healthy Volunteers of Both Sexes
Study Start Date : July 2016
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1.35 g SCMC- lys powder
1.35 g of SMC L-lysine monohydrate salt powder for solution
Drug: 1.35 g SCMC- lys powder
1.35 g SCMC- lys powder for oral solution
Other Name: Carbocisteine lysine salt 1.35 g powder for oral solution

Experimental: Fluifort® syrup
Fluifort® syrup 90 mg SCMC-lys/mL
Drug: Fluifort® syrup
SCMC-lys Syrup 90 mg/ml
Other Name: Carbocisteine lysine salt 90 mg/ml syrup

Primary Outcome Measures :
  1. Cmax [ Time Frame: 10 hrs ]
    Cmax of carbocysteine calculated from plasma concentrations after single oral dose

  2. AUC0-t [ Time Frame: 10 Hrs ]
    AUC0-t of carbocysteine calculated from plasma concentrations after single oral dose

Secondary Outcome Measures :
  1. AUC0-∞ [ Time Frame: 10 Hrs ]
    AUC0-∞ of carbocysteine calculated from plasma concentrations after single oral dose

  2. tmax [ Time Frame: 10 Hrs ]
    tmax of carbocysteine calculated from plasma concentrations after single oral dose

  3. t1/2 [ Time Frame: 10 Hrs ]
    t1/2 of carbocysteine calculated from plasma concentrations after single oral dose

  4. TEAEs [ Time Frame: Screening ]
    Treatment-emergent AEs

  5. TEAEs [ Time Frame: 10 Hrs ]
    Treatment-emergent AEs

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

To be enrolled in this study, subjects must fulfil all these criteria:

  1. Informed consent: signed written informed consent before inclusion in the study
  2. Sex and Age: males/females,18-55 years old inclusive
  3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
  4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, pulse rate (PR) 50-90 bpm and body temperature (BT) 35.5 - 37.5°C, measured after 5 min of rest in the sitting position;
  5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
  6. Contraception and fertility (females only): females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:

    1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit
    2. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after final visit
    3. A male sexual partner who agrees to use a male condom with spermicide
    4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test result must be negative at screening.

Exclusion Criteria:

Subjects meeting any of these criteria will not be enrolled in the study:

  1. Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities
  2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
  3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
  4. Allergy: ascertained or presumptive hypersensitivity to the active principles (carbocysteine-L-lysine salt) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to mucolytics) or allergic reactions in general, which the Investigator considers may affect the outcome of the study
  5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine or neurological and autoimmune diseases that may interfere with the aim of the study
  6. Medications: medications, including over the counter (OTC) drugs [in particular carbocysteine-L-lysine salt, carbocysteine and N-acetylcysteine, mucolytics and /or mucoregulators in general], herbal remedies and food supplements taken 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
  7. Investigative drug studies: participation in the evaluation of any investigational product for 6 months before this study. The 6-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the informed consent signature)
  8. Blood donation: blood donations for 3 months before this study
  9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010 [29]) caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥6 cigarettes/day)
  10. Drug test: positive result at the drug test at screening
  11. Alcohol test: positive alcohol breath test at day -1
  12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
  13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02858193

CROSS Research S.A., Phase I Unit
Arzo, Swiss, Switzerland, CH-6864
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Cross Research S.A.
Principal Investigator: Milko Radicioni, MD CROSS Research S.A., Phase I Unit

Responsible Party: Dompé Farmaceutici S.p.A Identifier: NCT02858193     History of Changes
Other Study ID Numbers: SCL0115
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Respiratory System Agents