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

NCT04941196 | Completed Phase 1 DMC

• 1 other identifier: CB-030-TIC-2019/Protocol/2.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bioequivalence Study; Pakistani Population; Bioavailability comparison

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum Plasma Drug concentration

  0-48 hours post dose

• Tmax

  Time required to reach maximum plasma Ticagrelor concentration

  0-48 hours post dose

• AUC

  Area under the plsama drug concentration versus time curve

  0-48 hours post dose

Secondary Outcomes (3)

• Blood pressure

  0-48 hours post dose

• Heart rate

  0-48 hours post dose

• Body temprature

  0-48 hours post dose

Study Arms (2)

Test Group

EXPERIMENTAL

Oral administration of Anplag® 90mg (Ticagrelor) whole Tablet, manufactured by PharmEvo Private Laboratories (Pak) Ltd., after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point.

Drug: Anplag (Ticagrelor 90 mg)

Reference Group

ACTIVE COMPARATOR

Oral administration of Brilinta® 90mg (Ticagrelor) Whole Tablet, manufactured by AstraZeneca Pharmaceuticals., after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point.

Drug: Brilinta (Ticagrelor 90 mg)

Interventions

Anplag (Ticagrelor 90 mg) DRUG

Ticagrelor 90 mg Immediate Release tablet

Test Group

Brilinta (Ticagrelor 90 mg) DRUG

Ticagrelor 90 mg Immediate Release tablet

Reference Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy adult Pakistani Male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male aged 18 to 55 years inclusive.
• Subjects with a body mass index from 18.5 to 30.0 kg/m2.
• Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-lead ECG and laboratory analysis (i.e., hematology, blood biochemistry, Serology and urinalysis), or as determined by the investigator.
• Subjects should have negative urine test for drugs of abuse (Opiates and cannabinoids will be tested) and negative result for alcohol breath test at screening and prior to each check-in
• Tested negative for COVID-19 (through COVID-19 antibody testing).
• Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra-uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug.
• All subjects should be free from any epidemic or contagious disease (e.g. Malaria, Dengue, COVID-19).
• Subjects are able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study Check-In day
• Subject agreed not to consume food or beverages like tea, coffee, cola drinks, chocolates containing Xanthene derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khashkhash) within 48-hours prior to drug administration until last blood draw in each study period.
• Subject agreed not to intake prescription medicine within 14 days or 5 half-lives (whichever is longer) prior to first dose of study medicine.
• Subject agreed not to intake non-prescription drugs (OTC such as aspirin, ibuprofen, naproxen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to increase the tendency for bleeding within 14 days prior to first dose of study medicine.
• Subject agreed to discontinue vitamins, dietary and herbal supplements within 14 days prior to the first dose of study medication.
• Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.

You may not qualify if:

• Refused to sign Informed Consent Form.
• Inability to take oral medication.
• Tested positive for COVID-19 (through COVID-19 antibody testing).
• History of smoking (\> 5 cigarette/day), alcoholism, and positive test for drug of abuse.
• Heavy pan or gutka user as judged by teeth/mouth inspection.
• Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
• Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
• History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
• Subject is allergic to Ticagrelor and/or other antiplatelet medications/platelet aggregation inhibitors.
• Subject has received any investigational drug within four weeks prior to screening.
• Subjects whose heart rate is abnormally low (usually lower than 60 beats per minute) and subject already have in place a device that paces the heart (pacemaker).
• Subjects with a history of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
• A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, non-traumatic bleeding, bleeding risks, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the investigator.
• Platelet count is less than 150 x 10\^9/L.
• Subject has had a blood test that showed more than the usual amount of uric acid.

Sponsors & Collaborators

• University of Karachi: lead
• PharmEvo Private Limited., Pakistan: collaborator

Study Sites (1)

Center for Bioequivalence Studies and clinical research

Karachi, Sindh, 75270, Pakistan

Location

Related Publications (1)

• Hashmi N, Jawaid M, Shah MR. Bioequivalence assessment of two Ticagrelor formulations under fasting condition in healthy Pakistani subjects. Pak J Med Sci. 2023 Nov-Dec;39(6):1647-1651. doi: 10.12669/pjms.39.6.8203.

  PMID: 37936786 DERIVED

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Prof. Dr. Muhammad R Shah, PhD

  Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

• Dr. Naghma Hashmi (Co-PI), PhD

  Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: single centre, cross over, single dose, two period, randomized, open label Bioequivalence Study

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 28, 2021
• Study Start: October 16, 2020
• Primary Completion: October 26, 2020
• Study Completion: November 25, 2020
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)