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Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet & Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition

NCT04941196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-08

No results posted yet for this study

Summary

Single oral administration of study drugs (i.e. Anplag® \& Brilinta®) in Two periods after at least 10 hours fasting. The periods will be separated by a washout period of 7 days. The purpose of this study is to compare the bioavailability of Anplag® 90mg (Ticagrelor) Tablet with Brilinta® 90 mg (Ticagrelor) Tablet under fasting conditions in healthy Pakistani male subjects.

Conditions

  • Healthy Individuals

Interventions

DRUG

Anplag (Ticagrelor 90 mg)

Ticagrelor 90 mg Immediate Release tablet

DRUG

Brilinta (Ticagrelor 90 mg)

Ticagrelor 90 mg Immediate Release tablet

Sponsors & Collaborators

  • PharmEvo Private Limited., Pakistan

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Prof. Dr. Muhammad R Shah, PhD · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

  • Dr. Naghma Hashmi (Co-PI), PhD · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2020-10-26
Completion
2020-11-25

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941196 on ClinicalTrials.gov