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Clinical Trials/CTRI/2023/04/051500
CTRI/2023/04/051500
Recruiting
Phase 1

A Phase I clinical study of intravenous administration of AntiPlatelet, AntiCoagulant (APAC) in healthy subjects.

Cadila Pharmaceutical Limited0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Cadila Pharmaceutical Limited
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Cadila Pharmaceutical Limited

Eligibility Criteria

Inclusion Criteria

  • •1\.Healthy subjects of either gender with \>\=18 and \<\=45 years of age.
  • •2\.Subjects able to understand and provide the written informed consent.
  • •3\.Subject willing to follow study schedules and all requirements of the study, in the PI/investigatorâ??s opinion.
  • •4\.Female subjects of childbearing potential having a negative urine pregnancy test prior to first dose of APAC.

Exclusion Criteria

  • •1\.Subjects with symptoms of fever or active infection, hemoglobin levels \<\= 11 g/dL, thrombocytopenia, (platelet count \< 100,000/cmm).
  • •2\.Subjects with a history of known sensitivity to heparin.
  • •3\.Subjects with an abnormal APTT, PT, TT, ACT, platelet aggregation studies, fibrinogen, D\-dimer, anti\-Factor IIa activity, anti\-Factor Xa activity and/or abnormal or prolonged ROTEM, VWF:Ag, FVIII or AT\-III value(s) at Screening.
  • •4\.Subject taking any prescription drugs or over the counter (OTC) medications, including herbal and ayurvedic medications at Screening.
  • •5\.Subjects with any other medical condition (a bleeding disorder), including any evidence of HIT, which in the opinion of the PI/investigator, should exclude them from the study.
  • •6\.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.
  • •7\.Female subjects who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception.
  • •8\.Subjects who for any reason, in the PI/investigatorâ??s opinion, are unsuitable for enrolment into the study.

Outcomes

Primary Outcomes

Not specified

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