Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
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?
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 1
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: 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
Outros nomes:
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Outros nomes:
|
|
Comparador Ativo: 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
Outros nomes:
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2
Prazo: 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
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Physical examination, clinical laboratory tests
Prazo: Screening, 2 day, 9 day, 13-15 day
|
Screening, 2 day, 9 day, 13-15 day
|
|
Vital sign
Prazo: 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
Prazo: 1 day, 2 day, 8 day, 9 day, 13-15 day
|
1 day, 2 day, 8 day, 9 day, 13-15 day
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: In-Jin Jang, Professor, Seoul National University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- GLIME_L_02279
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