CompletedNot Applicable

To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions

India42 participantsStarted 2024-08-30

Plain-language summary

* To compare and evaluate the oral bioavailability of Edoxaban 60 mg Film Coated Tablet with that of Lixiana® 60 mg filmtabletten (Film Coated Tablet (Edoxaban) in healthy, adult, human subjects under fasting conditions. * To monitor the safety and tolerability of the subjects.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. A physical examination (clinical examination) with no clinically significant finding.

What they're measuring

Maximum measured plasma concentration over the time span specified (Cmax)

Timeframe: 36 hours

The area under the plasma concentration versus time curve was calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt)

Timeframe: 36 hours

Trial details

NCT IDNCT06930937

SponsorHumanis Saglık Anonim Sirketi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-25

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