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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000668-27 |
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Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain.
The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.
The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
Period 1 : To Day -4 to Day 0
Day -4 at 8:00 am at Clinical Pharmacology Center
At day -3, -2 and -1 a salivary sample will be done to control the treatment compliance.
Day 0 at Clinical Pharmacology Center Clinical examination Measurement of the basal pain thresholds and pain evaluation (Visual Analog Scales) Blood and urinary sample (acetaminophen and GSH assay)
T0 : Administration of product: acetaminophen and [N-acetylcysteine or placebo]
T0+1H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+2H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood sample (acetaminophen assay)
T0+3H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+4H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood and urinary sample (acetaminophen, GSH, biochemistry assay)
- Lunch before departure
2 weeks of wash-out
Period 2 : To Day 17 to Day 21
Same of period 1. Subject who receives N-acétylcystéine in period 1 will receive placebo in second period and vice versa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetaminophen | Experimental | The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine. The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
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| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine combination with acetaminophen | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration | Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration (T0+1h, T0+2h, T0+3h, T0+4h). | At day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glutathione GSH concentration | Blood glutathione GSH concentration at J0 T0-1h and J0 T0+4h | At day 0 |
| Blood of acetaminophen concentration and its metabolites | Blood of acetaminophen concentration and its metabolites at J0 T0-1h, T0+2h, and T0+4h. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle PICKERING | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
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| at day 0 |
| Urinary assay of the rate of acetaminophen and its metabolites | Urinary assay of the rate of acetaminophen and its metabolites at J0 T0-1h, and T0+4h. | at day 0 |
| Pharmacogenetic dosage of enzymes involved in glutathione metabolism | at day 4 |
| Aniline Compounds |
| D000588 | Amines |