A Pharmacokinetic Profiling Study of combination of Camylofin 50 mg and Paracetamol 325 mg Single-Tablet regimen in healthy participants

ot Applicable0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in m2
•2. No significant diseases or clinically significant abnormal findings during screening, medical history or physical examination
•3. Healthy, as determined by medical history and clinical assessment of the investigator.
•4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study drug administration

•1. Abnormalities in the liver function tests (defined as SGOT / SGPT > 3 times the upper limit of normal)
•2. Abnormal renal function test (Creatinine > 1.4mg/dL)
•3. Moderate or Severe Anaemia (defined as Haemoglobin <10 g%)
•4. Participation in any clinical trial within 4 weeks prior to dosing.
•5. History of blood donation or bleeding of 300 mL or more of blood within 8 weeks prior to study start.
•6. History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis).
•7. Known hypersensitivity to Paracetamol
•8. Contraindications to Camylofin (See table 1)
•9. Pregnancy or breast-feeding women.
•10. Person on any concomitant medications
•11. Any other condition (for example: CCF) which the investigator believe would alter the pharmacokinetics/pharmacodynamics of the drug.
•12.Any other condition which the investigator feels might cause harm to the patient
•Table 1: Contraindications to Camylofin
•a.Narrow-angle glaucoma
•b.Prostatic hypertrophy
•c.Mechanical stenoses.
•d.Hypersensitivity to any of ingredients
•e.Pregnancy and lactation
•f.Children below 12 years
•g.Urinary retention

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