- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01888718
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of Allegra ® (Containing Fexofenadine Hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - Aventis U.S. LLC, Bridgewater, NJ 08807 in Healthy, Adult, Human Subjects Under Fasting Conditions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
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Hyderabad, Andhra Pradesh
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Balanagar, Hyderabad, Andhra Pradesh, Indien, 500 037
- Bioserve Clinical Research Private Limited
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
i. Provide written informed consent.
ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2.
iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
v. Female Subjects
- of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion Criteria
i.Incapable of understanding the informed consent.
ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
iv. Oral temperature is below 95.0°F or above 98.6°F.
v. Pulse rate below 50/min or above 100/min.
vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period.
ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
x. Habit of tobacco chewing.
xi. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
xii. Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
xiii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
xiv. Clinically significant abnormalities and / or with significant diseases. xv. Confirmed positive in alcohol screening.
xvi. Confirmed positive in selected drug of abuse.
xvii. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
xviii. Confirmed positive in urine pregnancy test.
xix. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Fexofenadine Hydrochloride Orally Disintegrating
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Andre navne:
|
Aktiv komparator: ALLEGRA
ALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under curve (AUC)
Tidsramme: Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs
|
Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dr. Vimal Teja, MD, Bioserve Clinical Research Private Limited
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 671/10
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Kliniske forsøg med Fexofenadine Hydrochloride
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University of California, San FranciscoFood and Drug Administration (FDA)RekrutteringHjælpestoffernes indvirkning på lægemiddelabsorptionForenede Stater
-
Wim DeraveUniversity of Copenhagen; Research Foundation FlandersAfsluttet
-
Opella Healthcare Group SAS, a Sanofi CompanyRekruttering
-
SanofiAfsluttet
-
University GhentResearch Foundation FlandersRekruttering
-
SanofiAfsluttet
-
Ardea Biosciences, Inc.AfsluttetGigtForenede Stater, Canada, Sydafrika, New Zealand, Belgien, Australien, Tyskland