Healthy VolunteerPhase 1NCT06244407
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions
A Phase 1 study testing Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets in people with Healthy Volunteer, run by International Bio service.
Trial summary
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2024to 2 Jun 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male or female subjects between the ages of 18 to 55 years
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
- Postmenopausal for at least 1 year
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- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
- Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Who cannot join
- History of allergic reaction or hypersensitivity to vildagliptin or metformin HCl or to any of the excipients
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- History or evidence of type 1 diabetes mellitus or lactic ketoacidosis or diabetic ketoacidosis
- Have abnormality of glucose (FBS)
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- Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening
- History or evidence of acute pancreatitis
- History or evidence of bullous pemphigoid or exfoliative skin lesion
- History or evidence of acute pancreatitis
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- History of problems with swallowing tablet or capsule
- Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- History of diarrhea or vomiting within 24 hours prior to check-in in each period
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 16.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
- 17.Have eGFR (CKD-EPI) <30 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment.
- 18.Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- 19.Investigation with blood sample shows positive test for HBsAg
- 20.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
- 21.History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.)
- 22.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of 1
- 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC
- 23.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
- 24.Consume or drink juice of grapefruit or orange or pomelo or its supplement / containing products and cannot abstain for at least 7 days prior to check-in in Period 1 and continued for entire duration of the study 25.Use of prescription or nonprescription drugs (e.g. paracetamol, furosemide, nifedipine, iodinated contrast agents, ranolazine, vandetanib, dolutegravir, cimetidine, phenothiazines, thyroid products, phenytoin, nicotinic acid, isoniazid., antidiabetic drugs (e.g. glyburide), NSAIDs, corticosteroids, sympathomimetic drugs, diuretics, antihypertensive drugs, etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study
- 26.Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study
- 27.Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment
- 28.Subjects with poor venous access or intolerant to venipuncture
- 29.Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study
- 30.Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT and Reference Product (Galvus Met®) in Healthy Thai Volunteers Under Fed Conditions
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
Read the detailed description
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
The manufacturer needs to formulate a generic Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT. This study has been planned to evaluate the pharmacokinetics of this formulation and determine its bioequivalence with the reference product, Galvus Met®, at the same dose.
- Conditions
- Healthy Volunteer
- Being tested
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Keywords
- Vildagliptin and Metformin Hydrochloride 50/1000 mg FCT, Bioequivalence Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated TabletsDrug
Also called Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets
Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated tablet | Experimental | Participants first received Vildagliptin and metformin HCl 50/1000 mg 1 tablet (Test product) in a fasting state. After a washout period of 7 days, they then recieved Galvus Met® 1 tablet (Reference product) in a fed state. Receives: Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets |
| Galvus Met® | Active comparator | Participants first received Galvus Met® 1 tablet (Reference product) in a fed state. After a washout period of 7 days, they then recieved Vildagliptin and metformin HCl 50/1000 mg (Test product) in a fed state. Receives: Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Area Under the Curve (AUC(0 to 36hr)) for Vildagliptin and Metformin
Plasma Area Under the Curve of Vildagliptin and Metformin
Measured: Through 36 Hours Post Dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start23 May 2024 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Bio service
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Uthai Suvanakoot, Ph.D.Pharm, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244407
- Sponsor's protocol ID
- BE23-014
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT and Reference Product (Galvus Met®) in Healthy Thai Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06244407
- Acronym / sponsor ID
- BE23-014
- Conditions
- Healthy Volunteer
- Keywords
- Vildagliptin and Metformin Hydrochloride 50/1000 mg FCT, Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Bio serviceResearch network
- Study start
- 23 May 2024 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 6 Feb 2024 (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 determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
Detailed description
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
The manufacturer needs to formulate a generic Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT. This study has been planned to evaluate the pharmacokinetics of this formulation and determine its bioequivalence with the reference product, Galvus Met®, at the same dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated tablet | Experimental | Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated TabletsParticipants first received Vildagliptin and metformin HCl 50/1000 mg 1 tablet (Test product) in a fasting state. After a washout period of 7 days, they then recieved Galvus Met® 1 tablet (Reference product) in a fed state. |
| Galvus Met® | Active comparator | Drug: Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated TabletsParticipants first received Galvus Met® 1 tablet (Reference product) in a fed state. After a washout period of 7 days, they then recieved Vildagliptin and metformin HCl 50/1000 mg (Test product) in a fed state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy Thai male or female subjects between the ages of 18 to 55 years
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
Key exclusion criteria (29 listed)
- History of allergic reaction or hypersensitivity to vildagliptin or metformin HCl or to any of the excipients
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- History or evidence of type 1 diabetes mellitus or lactic ketoacidosis or diabetic ketoacidosis
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 and Metformin Hydrochloride 50mg 1000 mg Film-coated TabletsAlso: Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated TabletsVildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets | Drug | Galvus Met®, Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated tablet |
Primary outcome
Plasma Area Under the Curve (AUC(0 to 36hr)) for Vildagliptin and Metformin
Time frame: Through 36 Hours Post Dose]
Plasma Area Under the Curve of Vildagliptin and Metformin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No. Confidential
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Screening Protocol
Pain
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.
Uthai Suvanakoot, Ph.D.Pharm principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets in people with Healthy Volunteer, run by International Bio service.
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 9 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanaporn Wongyai, B.Sc.Pharm (024415211 ext. 220, thanaporn.won@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Area Under the Curve (AUC(0 to 36hr)) for Vildagliptin and Metformin (time frame: Through 36 Hours Post Dose]). 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 7 Feb 2024.