To Determine Bioequivalence Under Fed ConditionsNCT05329857
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
A study testing Metformin and Vildagliptin 1000/50 mg in people with To Determine Bioequivalence Under Fed Conditions, run by AET Laboratories Private Limited.
Trial summary
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fed Conditions
- What is being tested?
- Metformin and Vildagliptin 1000/50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged between 18 and 45 years (both inclusive).
- Subjects' weight within the normal range according to normal values for the Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
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- Subjects having negative alcohol breath test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- No history or presence of smoking.
- No history or presence of alcoholism and drug of abuse.
Who cannot join
- Hypersensitivity to Vildagliptin or Metformin or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
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- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.
- Major illness during 3 months before screening.
- Donation of blood in the past 3 months before screening.
- Participation in drug research study within past 3 months.
- Consumption of grapefruit juice within 72.00 hours prior to dosing in Period 01 and xanthine-containing products, tobacco containing products or alcohol within 48.00 hours prior to dosing in Period 01.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
About this study
Official title: Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.
- Being tested
- Metformin and Vildagliptin 1000/50 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and Vildagliptin 1000/50 mgDrug
50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period
| Study group | Role | What they receive |
|---|---|---|
| Metformin and Vildagliptin 1000/50 mg Tablet | Experimental | 1 tablet of Metformin and Vildagliptin 1000/50 mg as single-dose administration Receives: Drug: Metformin and Vildagliptin 1000/50 mg |
| EUCREAS® 50/1000 mg Tablet | Active comparator | 1 tablet of EUCREAS® 50/1000 mg (each film-coated tablet contains Vildagliptin 50 mg and Metformin hydrochloride 1000 mg) as single-dose administration Receives: Drug: Metformin and Vildagliptin 1000/50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Vildagliptin and Metformin for the test and reference products
The maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: up to 24 hours
AUC0-t of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: up to 24 hours
Secondary outcomes (5)
AUC0-∞ of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: up to 24 hours
Tmax of Vildagliptin and Metformin for the test and the reference products
The time to maximum measured plasma concentration
Measured: up to 24 hours
T1/2 of Vildagliptin and Metfomin for the test and the reference products
Plasma elimination half-life
Measured: up to 24 hours
Kel of Vildagliptin and Metformin for the test and the reference products
Elimination rate constant
Measured: up to 24 hours
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study startDec 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fed ConditionsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AET Laboratories Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329857
- Sponsor's protocol ID
- 14-VIN-410
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT05329857
- Acronym / sponsor ID
- 14-VIN-410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AET Laboratories Private LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Apr 2022 (actual)
- 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.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin and Vildagliptin 1000/50 mg Tablet | Experimental | Drug: Metformin and Vildagliptin 1000/50 mg1 tablet of Metformin and Vildagliptin 1000/50 mg as single-dose administration |
| EUCREAS® 50/1000 mg Tablet | Active comparator | Drug: Metformin and Vildagliptin 1000/50 mg1 tablet of EUCREAS® 50/1000 mg (each film-coated tablet contains Vildagliptin 50 mg and Metformin hydrochloride 1000 mg) as single-dose administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male subjects aged between 18 and 45 years (both inclusive).
- Subjects' weight within the normal range according to normal values for the Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
Key exclusion criteria (18 listed)
- Hypersensitivity to Vildagliptin or Metformin or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
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 |
|---|---|---|
| Metformin and Vildagliptin 1000/50 mg50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period | Drug | EUCREAS® 50/1000 mg Tablet, Metformin and Vildagliptin 1000/50 mg Tablet |
Primary outcome
Cmax of Vildagliptin and Metformin for the test and reference products
Time frame: up to 24 hours
The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of Vildagliptin and Metformin for the test and the reference products
Time frame: up to 24 hours
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
5 secondary outcomes
AUC0-∞ of Vildagliptin and Metformin for the test and the reference products
Time frame: up to 24 hours
Tmax of Vildagliptin and Metformin for the test and the reference products
Time frame: up to 24 hours
T1/2 of Vildagliptin and Metfomin for the test and the reference products
Time frame: up to 24 hours
Kel of Vildagliptin and Metformin for the test and the reference products
Time frame: up to 24 hours
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Time frame: through study completion, an average of 1 month
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 15 Apr 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Vildagliptin 1000/50 mg in people with To Determine Bioequivalence Under Fed Conditions, run by AET Laboratories Private Limited.
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 10 inclusion and 18 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 15 Apr 2022. 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.
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?
Cmax of Vildagliptin and Metformin for the test and reference products (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 15 Apr 2022.