A Pharmacokinetic Study of Camylofin fixed dose combination with Paracetamol in healthy participants

Not Applicable

• Registration Number: CTRI/2021/03/032174
• Lead Sponsor: ot Applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess plasma pharmacokinetic profile of Camylofin after a single dose of Camylofin / Paracetomol Fixed Dose combination in normal healthy individuals both in fed & fasting states.Timepoint: Samples will be collected at time points (0 h, predosing) and 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8 hours

Secondary Outcome Measures

Name	Time	Method
To assess plasma pharmacokinetic profile of Paracetomol after a single dose of Camylofin / Paracetomol Fixed Dose combination in normal healthy individuals both in fed & fasting states.Timepoint: Samples will be collected at time points (0 h (predosing) and 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8 hours)