HealthyPhase 1NCT00934323
Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg
A Phase 1 study testing Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg in people with Healthy, run by Handok Inc. at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Apr 2009
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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?
- Conditions
- Healthy
- Being tested
- Amaryl M SR 1/500 mg, Amaryl M SR 2/500 mg
- Keywords
- volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amaryl M SR 1/500 mgDrug
Also called Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
Amaryl M SR 2/500 mgDrug
Also called Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg
single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
| Study group | Role | What they receive |
|---|---|---|
| TR sequential group | Experimental | Amaryl M SR 1/500 mg in period 1 and Amaryl M SR 2/500 mg in period 2 Receives: Drug: Amaryl M SR 1/500 mg; Drug: Amaryl M SR 2/500 mg |
| RT sequential group | Active comparator | Amaryl M SR 2/500 mg in period 1 and Amaryl M SR 1/500 mg in period 2 Receives: Drug: Amaryl M SR 1/500 mg; Drug: Amaryl M SR 2/500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast/D, Cmax/D
Measured: 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 (3)
Tmax, T1/2
Measured: 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
Vital signs, ECG, physical examination, clinical laboratory tests
Measured: screening, treatment period 1 & 2, Post-study visit
Adverse Event
Measured: Treatment period 1 & 2, Post-study visit
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 startOct 2008
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 33 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
- NCT00934323
- Sponsor's protocol ID
- M_SR_001
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27.
PubMed 22036245
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 SR 1/500mg and 2/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00934323
- Acronym / sponsor ID
- M_SR_001
- Conditions
- Healthy
- Keywords
- volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (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 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?
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 SR 1/500 mg, Drug: Amaryl M SR 2/500 mgAmaryl M SR 1/500 mg in period 1 and Amaryl M SR 2/500 mg in period 2 |
| RT sequential group | Active comparator | Drug: Amaryl M SR 1/500 mg, Drug: Amaryl M SR 2/500 mgAmaryl M SR 2/500 mg in period 1 and Amaryl M SR 1/500 mg in period 2 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 SR 1/500 mgAlso: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mgsingle oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group | Drug | RT sequential group, TR sequential group |
| Amaryl M SR 2/500 mgAlso: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mgsingle oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group | Drug | RT sequential group, TR sequential group |
Primary outcome
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
3 secondary outcomes
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
Vital signs, ECG, physical examination, clinical laboratory tests
Time frame: screening, treatment period 1 & 2, Post-study visit
Adverse Event
Time frame: Treatment period 1 & 2, Post-study visit
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.
- Derived from this study: PubMed 22036245Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg in people with Healthy, run by Handok Inc. at 1 site in South Korea.
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 11 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.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934323, which also lists 1 linked publication.
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.