Phase 1 N=24 PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Paracetamol Overdose
Primary: Safety Events — 6; 6; 6; 6 participants
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Phase 4 N=27 Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Drug Induced Liver Injury
Primary: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts — 0.0; 0.3; 0.3; 0.4 nmol/mL
N/A N=12 Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
Drug Mechanism · Healthy
Primary: Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol Measured by the Novel Electrochemical Method With Mass-spectrometry in Capillary Whole Blood Samples…
Phase 1 N=28 Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Parkinson's Disease
Primary: Cmax - Maximum Plasma Concentration — 895; 986 ng/mL
Phase 2 N=200 Effect of Paracetamol on the Common Cold
Common Cold
Primary: Breathing Scores Post 15 Minutes — 0.83; 0.11 Score on a Scale — p=<0.0001
Phase 2 N=250 Analgesic Effect of IV Acetaminophen in Tonsillectomies
Adenotonsillitis · Tonsillitis
Primary: FLACC Pain Score Greater Than or Equal to 4 — 58; 69 Participants
Phase 3 N=708 A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Pain
Primary: Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment — -28.25; -25.89; -25.74 millimeter(mm) — p=0.1626
Phase 4 N=276 Aminotransferase Trends During Prolonged Acetaminophen Dosing
Drug Toxicity · Healthy
Primary: The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations. — 204; 47; 1; 0 participants
Phase 4 N=21 Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
Acetaminophen Toxicity
Primary: Rise in Plasma Transaminases: Proportion of Responders. — 6; 8 Participants — p=0.59
Phase 3 N=100 Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Pain · Fever
Primary: Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) — 1; 1; 5; 25 Subjects
Phase 1 N=35 A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects
Pain
Primary: The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast]) — 47.18…
Phase 3 N=213 Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Acute Pain · Fever
Primary: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). — 77; 86; 26 Participants
Phase 4 N=393 Acetaminophen (APAP) +/- Oxycodone
Musculoskeletal Pain
Primary: Change in Pain Assessment — 2.9; 4.0 score on a scale
Phase 4 N=28 Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Gastrointestinal Mucosal Damage
Primary: Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule — 0.33; 1.48 Scores on a scale — p=<0.0001
Phase 1 N=32 Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Acute Pain
Primary: Paracetamol Peak Plasma Concentration (Cmax) After Single Dose — 2181.04 ng/mL
Phase 3 N=60 Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males
Fever
Primary: Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of…
N/A N=11 Tylenol Levels in Bariatric Patients
Obesity
Primary: Intra- and Post-operative Serum Concentrations — 17; 14; 9; 5 µg.mL-1
Phase 2 N=9 Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia
Phase 1: Pain Management · Phase 2: Pain Management
Primary: Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol — 0; 0; 0; 1 participants
N/A N=15 Effect on Acetaminophen Metabolism by Liquid Formulations
Acetaminophen Metabolism · Acetaminophen Poisoning · Drug Metabolism by Excipients
Primary: Acetaminophen Metabolites — 2.411; 2.009 mcg.hr/ml
Phase 4 N=50 Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Pain
Primary: Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen — 31.00; 28.51; 25.31; 52.38 hour*microgram per milliliter (h*mcg/mL)
N/A N=55 Mechanisms of Action of Acetaminophen
Myocardial Infarction · Arthritis
Primary: Percent Change in Serum Thromboxane B2 — 97.0; 97.4; 98.3; 96.7 Percent inhibition of baseline — p=>0.05
Phase 1 N=32 Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
Healthy Volunteers
Primary: Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose — 101.808; 114.957; NA; 118.528 ng/mL
Phase 3 N=162 IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
Acute Pain
Primary: Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment — 6.2; 5.4 units on a scale — p=0.08
Phase 2 N=60 Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
Pain, Postoperative
Primary: Pain Intensity at Rest Evaluated Using a 0-100 mm VAS — 9.6; 16.9; 18.4; 8.1 score on a scale
Phase 3 N=664 Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Post-operative Dental Pain
Primary: Time to Confirmed Perceptible Pain Relief — NA; 15.7; 20.2; 23.2 minutes — p=<0.001
Phase 3 N=341 Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Upper Respiratory Tract Infection · Nasal Congestion · Rhinorrhea
Primary: Physician Global Evaluation of Effectiveness on Nasal Symptoms — 1.9; 2.1 score on a scale
Phase 3 N=678 Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Post-operative Pain
Primary: Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) — 2.68; 3.30; 2.62; 1.93 units on a scale*hour — p=<0.0001
Phase 3 N=197 A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
Acute Pain
Primary: Total Rescue Opioid Consumption — 166.9; 179.9; 180.2 µg/kg — p=0.736
Phase 4 N=27 The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Pain
Primary: Post-operative Opioid Consumption — 228; 312 ug
Phase 4 N=31 Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)
Osteoarthritis, Knee
Primary: Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)] — NA; NA; NA Z-score