- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01068717
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
22. april 2015 oppdatert av: AstraZeneca
Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
27
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Austin, Texas, Forente stater, 78744
- PPD Development, LP
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Men and women, aged 18 to 55 years, inclusive
- Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- Body Mass Index of 18 to 32 kg/m^2, inclusive
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy to DPP-4 inhibitors or related compounds
- History of allergy or intolerance to metformin or other similar acting agents
- Previous exposure to saxagliptin
- Exposure to metformin within 3 months pervious to study drug administration
- Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
|
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Andre navn:
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Annen: Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
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Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
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Annen: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Andre navn:
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Annen: Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)
Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
|
Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Tidsramme: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
Tidsramme: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
Tidsramme: At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Clinically significant was determined by the investigator.
Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count.
Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase.
Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.
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At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Tidsramme: At screening visit, Day -1 of Period 1, and at study discharge
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Clinically significant was determined by the investigator.
ECGs were recorded after participants had been supine for at least 5 minutes.
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At screening visit, Day -1 of Period 1, and at study discharge
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Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
Tidsramme: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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Clinically significant was determined by the investigator.
Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
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At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2010
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. mars 2010
Datoer for studieregistrering
Først innsendt
12. februar 2010
Først innsendt som oppfylte QC-kriteriene
12. februar 2010
Først lagt ut (Anslag)
15. februar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehemmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hemmere
- Metformin
- Saksagliptin
Andre studie-ID-numre
- CV181-118
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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