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| Name | Class |
|---|---|
| PharmEvo Private Limited., Pakistan | UNKNOWN |
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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.
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 Blood samples will be withdrawn at pre-determined time points for estimation of plasma drug concentration upto 48 hours post dose.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anplag (Ticagrelor 90 mg) | Drug | Ticagrelor 90 mg Immediate Release tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | monitoring of blood pressure at specified time intervals | 0-48 hours post dose |
| Heart rate | Monitoring of Heart rate at pre-specified time intervals |
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Inclusion Criteria:
Exclusion Criteria:
Healthy adult Pakistani Male subjects
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Bioequivalence Studies and clinical research | Karachi | Sindh | 75270 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37936786 | Derived | 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. |
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Data can be obtained upon proper request to principal investigator unless the volunteer's confidentiality is not compromised.
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single centre, cross over, single dose, two period, randomized, open label Bioequivalence Study
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| Brilinta (Ticagrelor 90 mg) |
| Drug |
Ticagrelor 90 mg Immediate Release tablet |
|
| 0-48 hours post dose |
| Body temprature | measurement of body temperature at pre-determined time intervals | 0-48 hours post dose |
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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