2025-524663-20-00招募中1 期
A Randomized, Open label, Single Center, Single Oral Dose, Four Treatment, Four Period, Four Sequence, Crossover Bioavailability Study of Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) vs. Panadol Advance Tablets 2X (paracetamol 500 mg), Naprosyn Tablets 1X (naproxen 250 mg), administered individually in fasted conditions and Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) in fed conditions in Healthy Adult Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively
研究概览
简要总结
Assess the bioavailability (BA) of paracetamol and naproxen from Haleon FDC Tablets (paracetamol 500 mg/naproxen 125 mg) (Test) versus Naprosyn Tablets (naproxen 250 mg) (Reference 1) and Panadol Advance Tablets (paracetamol 500 mg) (Reference 2) under fasted condition
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed, including the genotyping to be performed.
- •Male or female participant who, at the time of screening, is between the ages of 18 and 55 years, inclusive.
- •Participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Healthy participant, which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
- •Body Mass Index (BMI) of 18.5 to 30.0 kg/m2; and a total body weight ≥ 50.0 kg for males and ≥ 50.0 kg for females.
- •Female participant of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last dose of assigned treatment.
排除标准
- •Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient.
- •Evidence of urinary obstruction (e.g. due to benign prostate hyperplasia) or difficulty in voiding at screening.
- •History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator.
- •Known allergic reactions (e.g., bronchospasm, rhinitis, angioedema, or urticaria) to the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to constituents of the pharmaceutical preparations.
- •Systolic blood pressure < 90 or > 139 mmHg.
- •Diastolic blood pressure < 50 or > 89 mmHg.
- •Heart rate < 50 bpm or > 90 bpm.
- •QTc interval > 450 ms for men and > 470 ms for women.
- •Screening laboratory results demonstrate blood urea nitrogen (BUN) (≥ 35 mg/dL) or instead urea (≥ 5.85 mmol/l); serum creatinine > 0.1 mg/dL above the laboratory reference upper limit, or estimated glomerular filtration rate (eGRF) ≥90 mL/min/1.73 m²; additionally the presence of protein or blood on urine dipstick testing at baseline is grounds for exclusion.
- •In case where screening values of gamma-glutamyl transferase (GGT), alanine aminotransferase (ALP), or aspartate aminotransferase (AST) exceed ≥ 1.2 ULN, or if bilirubin is > 20% ULN - an exception to the to the bilirubin criterion is made for subjects with documented Gilbert's syndrome and otherwise normal ALT, AST and ALP, where bilirubin may be up to 2x ULN.
- •Hemoglobin value < 12.0 g/dL for males and < 11.5 g/dL for females, corresponding to 7.452 mmol/l or 7.142 mmol/l for males and females, respectively.
- •Existing hepatic, pancreatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient.
- •Positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test, anti-HCV-test or HBc-Ab (IgG + IgM).
- •Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator.
- •Acute or chronic diseases which may interfere with the pharmacokinetics of the IMP.
- •History of or current alcohol dependence.
- •Positive alcohol, cotinine or drug test at screening examination.
- •Regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day.
- •History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
- •Blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the participant.
- •Current smoker, defined as the use of tobacco or nicotine products during the 3 months prior to screening until admission to the unit or a positive urine cotinine test at screening
- •Participants who are on a diet which could affect the pharmacokinetics of the active ingredient.
- •Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient.
- •Participants unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
- •Any history of long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
- •Participation in a clinical trial with administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the participant.
- •Simultaneous participation in another clinical trial with active ingredients.
- •Participants, who report a frequent occurrence of migraine attacks.
- •Positive pregnancy test at screening examination or at hospitalisation.
- •Pregnant or lactating women.
- •Female participants who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol).
- •Participant is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee of or student at the investigational site, employee of sponsor`s affiliates).
- •Participants suspected or known not to follow instructions.
- •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, e.g., appendectomy and herniorrhaphy).
- •Participants who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.
- •History of inflammatory bowel disease or gastrointestinal bleeding including peptic ulcers.
- •Existing metabolic (e.g. diabetes mellitus, metabolic syndrome), endocrine and/or immunologic diseases (e.g. autoimmune disorders) or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient.
- •Acute and/or history of relevant CNS and/or psychiatric disorders.
- •Clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.
- •Status of glutathione depletion due to metabolic deficiencies (i.e. due to eating disorders, cystic fibrosis, HIV infection, starvation, cachexia).
结局指标
主要结局
AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively
AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively
次要结局
- AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions
- Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively
- Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1
- Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2
- Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition
- Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments.
研究者
Haleon Contact Point Clinical trials
Scientific
Haleon CH SARL
研究点 (1)
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