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Completed

NCT Number: NCT00934323

Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg

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

* Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg? * What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: Between 20 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 caffein or caffein-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 72 hours before dosing and during the hospitalization
  • Subjects who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion criteria

  • History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing
  • Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 10 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included)
  • 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 of upper normal limit
  • 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 [e.g., brandy, whiskey, gin] per day) 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 participation of the study
  • Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study [Day 1].
  • Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody
  • Judged to be inappropriate for the study by the investigator

Treatment and study plan

Amaryl M SR 1/500 mg

Drug

single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group

Other names: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg

Amaryl M SR 2/500 mg

Drug

single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group

Other names: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg

Primary outcomes

  1. AUClast/D, Cmax/D

    Time frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration

Secondary outcomes

  1. Tmax, T1/2

    Time frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration

  2. Vital signs, ECG, physical examination, clinical laboratory tests

    Time frame: screening, treatment period 1 & 2, Post-study visit

  3. Adverse Event

    Time frame: Treatment period 1 & 2, Post-study visit

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jul 8, 2009
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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