HealthyNCT00806013
Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide
An observational study of Healthy, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 21 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Dec 2008
- Phase
- Observational
- 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 21 to 27 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male Chinese subjects with different geontype of CYP2C9 and CYP2C19 were enrolled in this study. They are divided into three groups by different geontype.
Who may be able to join
- nonsmokers and in good health
Who cannot join
- family history of diabetes mellitus
- taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study
Trial locations and contacts
1 site in 1 country.
China1 site
The second hospital to Liaoning University of TCM
Shenyang, Liaoning, 201203
About this study
Official title: Study the Effects of CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide in Healthy Chinese Subject
The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.
Read the detailed description
Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.
- Conditions
- Healthy
- Keywords
- genotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | CYP2C9*1/*1 and CYP2C19*1/*1 alleles carrier | |
| 2 | CYP2C19 PMs (CYP2C19*2/*2, CYP2C19*2/*3 or CYP2C19*3/*3) | |
| 3 | CYP2C9*1/*3 and CYP2C19*1/*1 alleles carrier |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startAug 2008
- Study completionDec 2008
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Investigators
- Bo Tan, Principal investigator, Shanghai Institute of Materia Medica, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806013
- Sponsor's protocol ID
- SIMM-080601
- Status last verified
- Dec 2008
- First submitted
- 9 Dec 2008
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effects of CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide in Healthy Chinese Subject
- ClinicalTrials.gov ID
- NCT00806013
- Acronym / sponsor ID
- SIMM-080601
- Conditions
- Healthy
- Keywords
- genotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Aug 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Dec 2008 (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 aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.
Detailed description
Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –CYP2C9*1/*1 and CYP2C19*1/*1 alleles carrier |
| 2 | – | –CYP2C19 PMs (CYP2C19*2/*2, CYP2C19*2/*3 or CYP2C19*3/*3) |
| 3 | – | –CYP2C9*1/*3 and CYP2C19*1/*1 alleles carrier |
Who may qualify
- Ages
- 21 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male Chinese subjects with different geontype of CYP2C9 and CYP2C19 were enrolled in this study. They are divided into three groups by different geontype.
Key inclusion criteria (1 listed)
- nonsmokers and in good health
Key exclusion criteria (2 listed)
- family history of diabetes mellitus
- taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Jan 2010.
- Our organizationLink provided by the sponsor.
- Chinese Academy of SciencesLink provided by the sponsor.
- National Natural Science Foundation of ChinaLink provided by the sponsor.
- ShangHai Institutes For Biological SciencesLink provided by the sponsor.
- Liaoning University of TCMLink provided by the sponsor.
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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.
Bo Tan principal investigator
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Chinese Academy of Sciences at 1 site in China.
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 1 inclusion and 2 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 27 Jan 2010. 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 China. 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.
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.
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 27 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.