- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01052909
Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting Condition
19. januar 2010 oppdatert av: Dr. Reddy's Laboratories Limited
Randomized, 2-way Crossover, Bioequivalence Study of Glimepiride 1 mg Tablets and Amaryl 1 mg Tablets in Healthy Subjects Under Fasting Condition
The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fasting condition.
Studieoversikt
Detaljert beskrivelse
The study was Single centre, randomized, single-dose, open-label,2-way crossover, bioequivalence study to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fasting condition.
Studietype
Intervensjonell
Registrering (Faktiske)
44
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
-
Sainte-Foy, Quebec, Canada, GIV 2KB
- Anapharm Inc
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or non-child-bearing potential female,smoker and or non-smoker,18 years of age and older.
- Capable of consent.
- Non-child-bearing potential female subject:
- Post-menopausal state:absence of menses for 12 months prior to drug. administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses & surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which,in the opinion of the Medical Sub-Investigator,would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B and C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- BMI≥30.0.
- History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (l Unit=150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to glimepiride or other sulfonylureas (e.g. chlopropamide,gliclazide, tolbutamide and glyburide).
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampinlrifabutin; examples of inhibitors: antidepressants, cimetidine. diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication. .
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea. inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism. or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological,endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication (including hormone therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Difficulty to swallow study medication.
- Smoking more than 25 cigarettes per day.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Sub-Investigator. contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
- 50 mL to 300 mL of whole blood within 30 days,
- 301 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Subjects with diabetes (including diabetes mellitus).
- Subjects with known serious hepatic impairments.
- Subjects with clinically significant presence or history of hypoglycemia.
Additional exclusion criteria for females only:
- Breast-feeding subject.
- Positive urine pregnancy test at screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Glimepiride
Glimepiride tablets 1 mg of Dr. Reddy's Laboratories Limited
|
Glimepiride tablets 1 mg
Andre navn:
|
Aktiv komparator: Amaryl
Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc
|
Glimepiride tablets 1 mg
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fasting condition
Tidsramme: 4 months
|
4 months
|
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. desember 2003
Primær fullføring (Faktiske)
1. desember 2003
Studiet fullført (Faktiske)
1. desember 2003
Datoer for studieregistrering
Først innsendt
19. januar 2010
Først innsendt som oppfylte QC-kriteriene
19. januar 2010
Først lagt ut (Anslag)
21. januar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. januar 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. januar 2010
Sist bekreftet
1. januar 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 30286
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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