CompletedPhase 1

Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray

India56 participantsStarted 2023-03-24

Plain-language summary

Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram in healthy adult human subjects.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Female of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first dosing day. They used an acceptable form of contraception.
✓. For female of childbearing potential, acceptable forms of contraception included the following:
✓. A physical examination (clinical examination) with no clinically significant finding.
✓. Results within normal limits or clinically non-significant for the following tests:

What they're measuring

Maximum measured plasma concentration(Cmax)

Timeframe: 120 hours

Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)

Timeframe: 120 hours

Trial details

NCT IDNCT06180083

SponsorHumanis Saglık Anonim Sirketi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-26

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