Trials / Completed
CompletedNCT04941196
Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet & Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Karachi · Academic / Other
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
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 Blood samples will be withdrawn at pre-determined time points for estimation of plasma drug concentration upto 48 hours post dose.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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anplag (Ticagrelor 90 mg) | Ticagrelor 90 mg Immediate Release tablet |
| DRUG | Brilinta (Ticagrelor 90 mg) | Ticagrelor 90 mg Immediate Release tablet |
Timeline
- Start date
- 2020-10-16
- Primary completion
- 2020-10-26
- Completion
- 2020-11-25
- First posted
- 2021-06-28
- Last updated
- 2022-09-08
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT04941196. Inclusion in this directory is not an endorsement.