At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years old (inclusive)
- ✓BMI 18.5–30 kg/m² (inclusive)
- ✓Normal vital signs: SBP 100–139 mmHg, DBP 50–89 mmHg, HR 50–90 bpm, temperature 35.5–37.5°C
- ✓Able to understand the study purpose, risks, and comply with requirements
- ✕Clinically significant ECG abnormalities
- ✕History of hypersensitivity to carbocysteine-L-lysine salt, mucolytics, or formulation ingredients
- ✕Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine, neurological, or autoimmune disease
- ✕Abnormal laboratory values indicative of physical illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
2-way Crossover, Randomised, Single Dose and 2-stage Bioequivalence Phase I Study of Carbocysteine-L-lysine Salt 1.35 g Powder for Oral Solution Formulation vs 90 mg/mL Syrup Formulation After Oral Administration to Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating SCMC-lys powder 1.35 g and Fluifort® syrup for Bronchitis. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Objectives: The objectives of the study was 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. Primary end-point: to evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of carbocysteine after single oral administration of test and reference. Secondary end-points: * to describe the pharmacokinetic (PK) profile of carbocysteine after single oral administration of test and reference products; * to collect safety and tolerability data after single oral administration of test and reference products.
Study Details
Timeline
Interventions
Powder for oral solution in sachets each containing 1.35 g of S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys). One sachet of the powder of the test formulation: (1.35 g of SCMC-lys corresponding to 750 mg of carbocysteine-free base) was dissolved in 100 mL of hot (not boiling) still mineral water. Additional 100 mL of still mineral water at room temperature were added and mixed. The solution was swallowed and the glass was rinsed with 40 mL of still mineral water that was also drunk by the subjects. The final administered volume was 240 mL. All subjects were in fasting conditions from the evening before (at least 10 h, overnight).The final administered volume was 240 mL for both the test and reference treatments.
Fluifort® 90 mg/mL syrup (15 mL corresponding to 1.35 g SCMC-lys) Fifteen (15) mL of syrup (1.35 g of SCMC-lys corresponding to 750 mg of carbocysteine-free base) poured in a glass were drunk by the subjects. Afterward, the glass was rinsed twice with a volume of 100 mL and 125 mL of still mineral water and the rinses were drunk immediately by the subjects. The final administered volume was 240 mL for both the test and reference treatments.