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EC number: 245-826-4 | CAS number: 23694-14-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- pharmacokinetics
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Absolute bioavailability, rate of absorption, and dose proportionality of sulpiride in humans.
- Author:
- Bressolle F
- Year:
- 1 992
- Bibliographic source:
- J. Pharm. Sci. 1992; 81: 26-32, (REF 29).
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sulpiride
- EC Number:
- 239-753-7
- EC Name:
- Sulpiride
- Cas Number:
- 15676-16-1
- Molecular formula:
- C15H23N3O4S
- IUPAC Name:
- N-[(1-ethylpyrrolidin-2-yl)methyl]-2-methoxy-5-sulfamoylbenzamide
Constituent 1
- Specific details on test material used for the study:
- Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Method
- Ethical approval:
- not specified
- Exposure assessment:
- measured
- Details on exposure:
- 12 healthy subjects received an oral solution of 200 mg drug and an intravenous (IV) and intramuscular (IM) dose of 100 mg drug, in 6 healthy subjects who received an oral capsule of 200, 300, and 400 mg drug, and an IV injection of 100 mg drug, and in 8 healthy male subjects who received an oral capsule and IM dose of 200 mg drug.
Results and discussion
- Results:
- Drug disposition was best described by a 2-compartment model, with absorption appearing to occur by 2 sequential zero-order processes. The fraction of dose absorbed after oral administration was about 30%, based on plasma and urine data. After the 200 mg dose, mean elimination half-life was 7 h and mean residence time was 8.4 h. For each subject total clearance, corrected for the fraction absorbed, and renal clearance were similar. The dose proportionality study demonstrated linear disposition kinetics.
Applicant's summary and conclusion
- Conclusions:
- The dose absorbed after oral administration was about 30%. After the 200 mg dose, mean elimination half-life was 7 h and mean residence time was 8.4 h.
- Executive summary:
12 Healthy subjects received an oral solution of 200 mg drug and an intravenous (IV) and intramuscular (IM) dose of 100 mg drug, in 6 healthy subjects who received an oral capsule of 200, 300, and 400 mg drug, and an IV injection of 100 mg drug, and in 8 healthy male subjects who received an oral capsule and IM dose of 200 mg drug.
Drug disposition was best described by a 2-compartment model, with absorption appearing to occur by 2 sequential zero-order processes. The fraction of dose absorbed after oral administration was about 30%, based on plasma and urine data. After the 200 mg dose, mean elimination half-life was 7 h and mean residence time was 8.4 h. For each subject total clearance, corrected for the fraction absorbed, and renal clearance were similar. The dose proportionality study demonstrated linear disposition kinetics.
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