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Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg

7 juli 2009 bijgewerkt door: Handok Inc.

An Open, Randomized, Two-Treatment, Crossover Study to Assess the Dose Proportionality of Glimepiride Between Amaryl M 1mg/500mg and 2mg/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Subjects

The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose intake of both combinations in order to answer the following questions:

  • Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard to the glimepiride component?
  • Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

16 subjects were randomized to each of 2 sequence groups which have different treatment order of the study drug in each period.

Only healthy volunteers had screening tests such as medical inquiry, physical examination, clinical laboratory test, etc. within 4 weeks (-28d ~ -1d) prior to drug administration (1d) and those determined eligible for this study were selected and randomized between screening and 1 day prior to the first administration of study medication (-1d). Then, the subjects were admitted to the clinical research center of Seoul National University Hospital by 9 p.m. of -1d and then, they were not allowed to take anything except water.

After one week of washout period, subjects went on to the second phase of treatment period and were administered according to the treatment order in a crossover way. For the subjects who completed the study, post-study visit tests were performed after a designated time had passed.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

36

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age: Between 19 to 45 years of age, inclusive (age based on the date to give the informed consent)
  • Ideal body weight (Broca index): between 50 to 90 kg, inclusive, and within ±20 % of Ideal Body Weight, [(Height in cm-100)×0.9]
  • Subjects who are appropriate to participate in this study judged from clinical laboratory and physical examinations taken within 4weeks prior to the start of study
  • Subjects who are able to abstain from caffeine or caffeine-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 7 days before dosing and during the hospitalization
  • Subjects who give their informed consent voluntarily to participate in the study

Exclusion Criteria:

  • History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing
  • Use any medication not considered acceptable by the clinical investigator during the last 10 days period before the start day of the study
  • Use of any inducer or inhibitors of metabolizing enzymes during the last 28 days before the start day of the study.
  • History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
  • History of a significant surgical resection of gastrointestinal tract except appendectomy
  • Abnormal clinical laboratory findings, especially for AST or ALT > 1.25 fold, total bilirubin > 1.5 fold of upper normal level
  • Pregnant or lactating woman or woman of childbearing potential without medically acceptable birth control during the study
  • Evidence of alcohol abuse (defined as regular alcohol intake that exceeds 24 oz [675 ml] of beer, 12 oz [340 ml] of wine or 160 ml of soju or 3 oz [85 ml] hard liquor per day [e.g., brandy, whiskey, gin]) or drug abuse
  • Heavy smokers (> 10 cigarettes per day), or can't quit smoking during hospitalization
  • Participation in clinical trials of any drug within 3 months prior to the start of study
  • Donation of 200ml of whole blood within 4 weeks or 400ml within 12 weeks prior to the start of study
  • Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody
  • Judged to be inappropriate for the study by the investigator

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TR sequential group
Amaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2
single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
Andere namen:
  • glimepiride 2 mg & metformin HCl 500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Andere namen:
  • glimepiride 1 mg & metformin HCl 500 mg
Actieve vergelijker: RT sequential group
Amaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2
single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
Andere namen:
  • glimepiride 2 mg & metformin HCl 500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Andere namen:
  • glimepiride 1 mg & metformin HCl 500 mg

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2
Tijdsspanne: pre-dose (= 1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 30 hrs after drug administration
pre-dose (= 1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 30 hrs after drug administration

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Physical examination, clinical laboratory tests
Tijdsspanne: Screening, 2 day, 9 day, 13-15 day
Screening, 2 day, 9 day, 13-15 day
Vital sign
Tijdsspanne: screening, 1 day, 2 day, 8 day, 9 day, 13-15 day
screening, 1 day, 2 day, 8 day, 9 day, 13-15 day
Adverse event
Tijdsspanne: 1 day, 2 day, 8 day, 9 day, 13-15 day
1 day, 2 day, 8 day, 9 day, 13-15 day

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: In-Jin Jang, Professor, Seoul National University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2007

Primaire voltooiing (Werkelijk)

1 mei 2007

Studie voltooiing (Werkelijk)

1 augustus 2007

Studieregistratiedata

Eerst ingediend

6 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2009

Eerst geplaatst (Schatting)

8 juli 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

8 juli 2009

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2009

Laatst geverifieerd

1 juli 2009

Meer informatie

Termen gerelateerd aan deze studie

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