- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00870571
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fed Conditions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers under FedConditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
- MDS Pharma Services
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male or female volunteers, 18-55 years of age;
- Subject will be non-smokers or moderate smokers (less than 10 cigarettes a day) for at least 3 months.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 14 days following the last dose or be using one of the following acceptable birth control methods:
- surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- IUD in place for at least 3 months.
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study, and for 14 days following the last dose.
- surgical sterilization of the partner (vasectomy for 6 months minimum).
hormonal contraceptives for at least 3 months prior to the first dose of the study and for 14 days following the last dose.
Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
- Give voluntary written informed consent to participate in the study.
Exclusion Criteria:
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers.
- Female subjects who are pregnant or lactating.
- SUbjects who tested positive at screening for HIV, HbsAg or HeV.
- Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
- Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
- Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
- Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood In 14 days; 1500 mL of blood in 160 days; 2500 mL of blood In 1 year.
- Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: EN
AMLODIPIN (som BESILAT) TABLETTER 10 mg, enkeltdosis
|
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD.
formulated products under fed conditions
Andre navne:
|
Aktiv komparator: B
NorvasC® 10 mg Tablets, single dose
|
B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Absorptionshastighed og forlængelse
Tidsramme: 72 timer
|
72 timer
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gaetano Morelli,, MD, MDS Pharma Services
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
- 24309
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose
-
Actavis Inc.Afsluttet