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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier:
NCT02858193
First received: July 29, 2016
Last updated: August 3, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Bronchitis Drug: 1.35 g SCMC- lys powder Drug: Fluifort® syrup Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dompé Farmaceutici S.p.A:

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

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


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

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

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

  • TEAEs [ Time Frame: Screening ]
    Treatment-emergent AEs

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


Estimated Enrollment: 30
Study Start Date: July 2016
Estimated Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02858193

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

Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT02858193     History of Changes
Other Study ID Numbers: SCL0115
Study First Received: July 29, 2016
Last Updated: August 3, 2016
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on June 23, 2017