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Healthy IndividualsPhase 1BENCT04941196

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

A Phase 1 study testing Anplag (Ticagrelor 90 mg) and Brilinta (Ticagrelor 90 mg) in people with Healthy Individuals, run by University of Karachi at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Individuals
What is being tested?
Anplag (Ticagrelor 90 mg) and Brilinta (Ticagrelor 90 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
16 Oct 2020to 25 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects receiving oral anticoagulants often referred to as "blood thinners" which include warfarin.
  • History of any significant illness in the last four weeks .
  • Consumption of grapefruit and/or its products within 14 days prior to the start of study.
  • Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV), human immunodeficiency virus (HIV-1 or HIV-2) or COVID-19.
  • Individuals having undergone any major surgery (including dental work) within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
  • Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or pose any risk in administrating Ticagrelor to the subject.
  • Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Center for Bioequivalence Studies and clinical research

    Karachi, Sindh, 75270

Other trials in Pakistan

About this study

Official title: A Single Centre, Cross-over, Single Dose, Two Period, Randomized, Open Label Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet With Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition

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.

Read the detailed description

The subjects will be randomly assigned in period 1 to T or R sequence and will be administered the study drugs T (Anplag® 90 mg) or R (Brilinta® 90 mg) with 240 mL ambient temperature water following at least 10 hours fasting. Blood samples will be withdrawn at pre-determined time points for estimation of plasma drug concentration upto 48 hours post dose. the subjects will be crossed over in Period 2 separated by a washout period of 7 days and administered RT sequence in period 2. Similar procedure of blood sampling will be applied for estimation of plasma drug concentration upto 48 hours post dose.

Being tested
Anplag (Ticagrelor 90 mg), Brilinta (Ticagrelor 90 mg)
Keywords
Bioequivalence Study, Pakistani Population, Bioavailability comparison

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anplag (Ticagrelor 90 mg)Drug

    Ticagrelor 90 mg Immediate Release tablet

  • Brilinta (Ticagrelor 90 mg)Drug

    Ticagrelor 90 mg Immediate Release tablet

Study groups in NCT04941196
Study groupRoleWhat they receive
Test GroupExperimentalOral 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.
Receives: Drug: Anplag (Ticagrelor 90 mg)
Reference GroupActive comparatorOral 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.
Receives: Drug: Brilinta (Ticagrelor 90 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximum Plasma Drug concentration

    Measured: 0-48 hours post dose

  2. Tmax

    Time required to reach maximum plasma Ticagrelor concentration

    Measured: 0-48 hours post dose

  3. AUC

    Area under the plsama drug concentration versus time curve

    Measured: 0-48 hours post dose

Secondary outcomes (3)

  1. Blood pressure

    monitoring of blood pressure at specified time intervals

    Measured: 0-48 hours post dose

  2. Heart rate

    Monitoring of Heart rate at pre-specified time intervals

    Measured: 0-48 hours post dose

  3. Body temprature

    measurement of body temperature at pre-determined time intervals

    Measured: 0-48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start16 Oct 2020
  3. Primary completion26 Oct 2020
  4. Study completion25 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
single centre, cross over, single dose, two period, randomized, open label Bioequivalence Study
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941196
Sponsor's protocol ID
CB-030-TIC-2019/Protocol/2.0
Acronym
BE
Status last verified
Sep 2022
First submitted
19 Jun 2021
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data can be obtained upon proper request to principal investigator unless the volunteer's confidentiality is not compromised.

Publications

  • 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.

    PubMed 37936786

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anplag (Ticagrelor 90 mg) and Brilinta (Ticagrelor 90 mg) in people with Healthy Individuals, run by University of Karachi at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 0-48 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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