HealthyPhase 1NCT00414947
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers
A Phase 1 study testing Vildagliptin (LAF237) in people with Healthy, run by Novartis at 1 site in China.
Trial summary
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers. This trial is not recruiting patients in the United States, Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vildagliptin (LAF237)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2006to not given
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy male subjects age 18 to 40 years of age included
- In good health
- Male subjects using a double-barrier local contraception for the entire duration of the study up to study completion visit and refraining from fathering a child in the three months following last study drug administration.
- Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg
Who cannot join
- Smokers
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
- Participation in any clinical investigation within 4 weeks prior to dosing.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities.
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- History of:
- Fainting, low blood pressure when standing, irregular heartbeats,
- Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
- Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- Known hypersensitivity to the study drug or similar drugs
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
- Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- Drug or alcohol abuse within the 12 months prior to dosing
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Open-Label, Crossover, Single Oral Dose Study to Assess the Bioequivalence of LAF237 Tablet Manufactured by Beijing Novartis Pharma Ltd. to Imported LAF237 Tablet in Chinese Healthy Subjects
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers.
This trial is not recruiting patients in the United States,
- Conditions
- Healthy
- Being tested
- Vildagliptin (LAF237)
- Keywords
- Bioequivalence, safety, LAF237, vildagliptin, Chinese, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin (LAF237)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. to imported vildagliptin tablet in Chinese healthy subjects
Secondary outcomes (1)
Safety and tolerability of vildagliptin tablet after a 50 mg single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414947
- Sponsor's protocol ID
- CLAF237A2111
- Status last verified
- Jun 2007
- First submitted
- 21 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-Label, Crossover, Single Oral Dose Study to Assess the Bioequivalence of LAF237 Tablet Manufactured by Beijing Novartis Pharma Ltd. to Imported LAF237 Tablet in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT00414947
- Acronym / sponsor ID
- CLAF237A2111
- Conditions
- Healthy
- Keywords
- Bioequivalence, safety, LAF237, vildagliptin, Chinese, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 22 Dec 2006 (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.
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers.
This trial is not recruiting patients in the United States,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese healthy male subjects age 18 to 40 years of age included
- In good health
- Male subjects using a double-barrier local contraception for the entire duration of the study up to study completion visit and refraining from fathering a child in the three months following last study drug administration.
- Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg
Key exclusion criteria (16 listed)
- Smokers
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
- Participation in any clinical investigation within 4 weeks prior to dosing.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
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 |
|---|---|---|
| Vildagliptin (LAF237) | Drug | – |
Primary outcome
Rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. to imported vildagliptin tablet in Chinese healthy subjects
1 secondary outcome
Safety and tolerability of vildagliptin tablet after a 50 mg single dose
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 22 Jun 2007.
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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.
Novartis principal investigator
Investigator site
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 Vildagliptin (LAF237) in people with Healthy, run by Novartis 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 4 inclusion and 16 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 22 Jun 2007. 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.
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?
Rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. to imported vildagliptin tablet in Chinese healthy subjects. 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 22 Jun 2007.