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Clinical Trials/CTRI/2021/03/032174
CTRI/2021/03/032174
Not yet recruiting
未知

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

ot Applicable0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
ot Applicable
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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