HealthyPhase 1NCT00934817
Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
A Phase 1 study testing Amaryl-M 2/500 mg and Amaryl-M 1/500 mg in people with Healthy, run by Handok Inc..
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Amaryl-M 2/500 mg and Amaryl-M 1/500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Aug 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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?
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Amaryl-M 2/500 mg, Amaryl-M 1/500 mg
- Keywords
- Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amaryl-M 2/500 mgDrug
Also called glimepiride 2 mg & metformin HCl 500 mg
single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
Amaryl-M 1/500 mgDrug
Also called glimepiride 1 mg & metformin HCl 500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
| Study group | Role | What they receive |
|---|---|---|
| TR sequential group | Experimental | Amaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2 Receives: Drug: Amaryl-M 2/500 mg; Drug: Amaryl-M 1/500 mg |
| RT sequential group | Active comparator | Amaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2 Receives: Drug: Amaryl-M 2/500 mg; Drug: Amaryl-M 1/500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2
Measured: 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
Secondary outcomes (3)
Physical examination, clinical laboratory tests
Measured: Screening, 2 day, 9 day, 13-15 day
Vital sign
Measured: screening, 1 day, 2 day, 8 day, 9 day, 13-15 day
Adverse event
Measured: 1 day, 2 day, 8 day, 9 day, 13-15 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2007
- Primary completionMay 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- In-Jin Jang, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934817
- Sponsor's protocol ID
- GLIME_L_02279
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00934817
- Acronym / sponsor ID
- GLIME_L_02279
- Conditions
- Healthy
- Keywords
- Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR sequential group | Experimental | Drug: Amaryl-M 2/500 mg, Drug: Amaryl-M 1/500 mgAmaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2 |
| RT sequential group | Active comparator | Drug: Amaryl-M 2/500 mg, Drug: Amaryl-M 1/500 mgAmaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amaryl-M 2/500 mgAlso: glimepiride 2 mg & metformin HCl 500 mgsingle oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively | Drug | RT sequential group, TR sequential group |
| Amaryl-M 1/500 mgAlso: glimepiride 1 mg & metformin HCl 500 mgsingle oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively | Drug | RT sequential group, TR sequential group |
Primary outcome
Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2
Time frame: 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
3 secondary outcomes
Physical examination, clinical laboratory tests
Time frame: Screening, 2 day, 9 day, 13-15 day
Vital sign
Time frame: screening, 1 day, 2 day, 8 day, 9 day, 13-15 day
Adverse event
Time frame: 1 day, 2 day, 8 day, 9 day, 13-15 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, Professor principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amaryl-M 2/500 mg and Amaryl-M 1/500 mg in people with Healthy, run by Handok Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.