Fed ConditionsPhase 1NCT06073600
Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®
A Phase 1 study testing Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) and Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) in people with Fed Conditions, run by Reseach Laboratory of Clinical and Experimental Pharmacology at 1 site in Tunisia.
Trial summary
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fed Conditions
- What is being tested?
- Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) and Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTunisia
- Study dates
- 20 May 2022to 13 Nov 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is aged between eighteen to fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index (BMI) range (18.5 - 30.0 Kg/m2).
- The subject is able to understand and willing to sign the Informed Consent Form.
- The subject has completed his Coronavirus 19 vaccination schedule. E. The subject is willing to undergo the necessary medical examinations pre- during \& post-study.
- There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- The results of medical history, physical examination, vital signs, conducted medical laboratory tests \& ECG recording are normal as determined by the investigator.
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- The subject tested negative for Hepatitis B (HBsAg) and Hepatitis C (HCVAb). I. For female subjects: negative pregnancy test and the woman is using two reliable contraception methods and should be non-lactating.
- Non-inclusion Criteria:
- The subject is a heavy smoker (more than 10 cigarettes per day). B. The subject has a history of or concurrent abuse of alcohol. C. The subject has a history of or concurrent abuse of illicit drugs. D. The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- The subject is vegetarian. F. The subject has suffered an acute illness within seven (7) days before first dosing (declared before inclusion).
- The subject has been hospitalized within three (3) months before the study. H. The subject has taken a prescription medication within two weeks or even an over-the-counter product (OTC) within seven (7) days before first dosing.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing (declared before inclusion).
- The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- The subject has been participating in any clinical study (e.g. PKs, BA and BE studies) within the last 80 days prior to the present study.
- The subject has donated blood within 80 days before first dosing.
Who cannot join
- The subject has suffered an acute illness within seven (7) days before dosing (declared after inclusion).
- The subject has been hospitalized during the study. C. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two (2) days before dosing and until 12 Hrs after dosing in both study periods.
- The subject has taken a prescription medication within two (2) weeks or even an OTC within seven (7) days before first dosing and any time during the study unless otherwise judged acceptable by the investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before dosing (declared after inclusion) and any time during the study.
- The subject underwent a radiological examination with an injection of Iodinated Contrast Media within 48 hours before first dosing.
- The subject has a positive Covid-19 rapid test.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Centre National Chalbi Belkahia de Pharmacovogilance
Tunis, 1006
About this study
Official title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Metformin / Vildagliptin Film Coated Tablets (1000 mg/50 mg) Versus Galvumet® Film Coated Tablets (1000 mg/50 mg)
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.
Read the detailed description
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.
Products under investigation for this study:
Test Product: Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia.
Reference Product: Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
Metformin and vildagliptin are two oral antidiabetic drugs. Metformin belongs to biguanide class. Vildagliptin is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4).
Metformin and vildagliptin are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type two diabetes mellitus.
This study will be conducted according to the principles of Good Clinical Practice (GCP) that have their origins in the Declaration of Helsinki.
This study will be subject to the review and approval of Persons Protection Committee and of Pharmacy and Medicine Department.
Subjects will not be recruited without obtaining their informed consent. Subjects will be covered for adverse events through an insurance company. Subjects will be housed in each study period at least 12 hours before dose administration and until 36 hours after dosing.
Subjects will be in a sitting position on chairs for the first 4 hours that follow the dose.
After an overnight fast of ten to twelve (10-12) hours and in the morning of the second day of each study period (day 2), a standard high-fat breakfast (800-1000 calories) will be served to subjects, thirteen (30) minutes before dosing.
At 08:00 am, the study products will be administered orally in a randomized fashion with 240 ± 2 mL warm 20% glucose solution.
During each period of the study, 21 blood samples of 7 mL each will be collected (via an indwelling cannula into lithium heparin tubes) according to the following schedule: Pre dosing (zero time) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.5, 3.00, 3.50, 4.00, 4.5, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 \& 36.00 hours post dosing.
After collection, the blood samples will be placed in an ice bath or other chilling device until centrifugation.
Before each period of the study, 21 mL blood sample will be collected for bio-analytical purposes.
A blood sample of 3 mL may be needed for a possible control. Samples will be centrifuged at 4000 round per minute for 5 minutes at 10°C. Supernatant plasma will be transferred to pre-labeled polypropylene Eppendorf tubes and stored in freezers at nominal temperature of -20 C unless otherwise advised by the stability studies on samples.
Samples from all subjects will be analyzed at the bio-analytical site of the National Center of Pharmacovigilance according to validated in-house procedure using validated Liquid Chromatography-Mass Spectrometry Tandem method for the plasma concentrations of metformin \& vildagliptin.
Primary end points would be obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax, Air Under Cover (AUC) 0 - t \& AUC 0 - ∞.
Secondary end points would be obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Tmax, T half \& K elimination (λz).
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data of the following primary end points for metformin \& vildagliptin: Cmax, AUC 0 - t \& AUC 0 - ∞ and if there were no safety concerns and both products were well tolerated by the study subjects.
- Conditions
- Fed Conditions
- Being tested
- Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®), Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)
- Keywords
- Bioequivalence, Metformin, Vildagliptin, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®)Drug
Also called Galvumet®
The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).
Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)Drug
Also called BiGalvine
The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).
| Study group | Role | What they receive |
|---|---|---|
| First group of healthy volunteers | Experimental | The first group of healthy volunteers, defined by randomization Receives: Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®); Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) |
| Second group of healthy volunteers | Active comparator | The second group of healthy volunteers, defined by randomization Receives: Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®); Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax.
Measured: 2 - 4 Hours
AUC 0 - t
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: AUC 0 - t.
Measured: 0 - 24 Hours
Secondary outcomes (3)
Tmax
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Tmax
Measured: 2 - 4 Hours
T half
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: T half
Measured: 7 days
K elimination (λz)
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: K elimination (λz)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start20 May 2022
- Primary completion9 Sep 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reseach Laboratory of Clinical and Experimental Pharmacology
- Sponsor type
- Research network
- Collaborators
- La Société Arabe des Industries Pharmaceutiques-Tunisie, Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie
- Responsible party
- Principal investigator, Sameh Trabelsi, Reseach Laboratory of Clinical and Experimental Pharmacology
- Investigators
- Sameh Trabelsi, Principal investigator, Research Laboratory of Clinical and experimental Pharmacology LR16SP02
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073600
- Sponsor's protocol ID
- CNPVBE02-2022
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Metformin / Vildagliptin Film Coated Tablets (1000 mg/50 mg) Versus Galvumet® Film Coated Tablets (1000 mg/50 mg)
- ClinicalTrials.gov ID
- NCT06073600
- Acronym / sponsor ID
- CNPVBE02-2022
- Conditions
- Fed Conditions
- Keywords
- Bioequivalence, Metformin, Vildagliptin, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Reseach Laboratory of Clinical and Experimental PharmacologyResearch network
- Collaborators
- La Société Arabe des Industries Pharmaceutiques-Tunisie, Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie
- Study start
- 20 May 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 10 Oct 2023 (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.
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.
Detailed description
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.
Products under investigation for this study:
Test Product: Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia.
Reference Product: Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
Metformin and vildagliptin are two oral antidiabetic drugs. Metformin belongs to biguanide class. Vildagliptin is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4).
Metformin and vildagliptin are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type two diabetes mellitus.
This study will be conducted according to the principles of Good Clinical Practice (GCP) that have their origins in the Declaration of Helsinki.
This study will be subject to the review and approval of Persons Protection Committee and of Pharmacy and Medicine Department.
Subjects will not be recruited without obtaining their informed consent. Subjects will be covered for adverse events through an insurance company. Subjects will be housed in each study period at least 12 hours before dose administration and until 36 hours after dosing.
Subjects will be in a sitting position on chairs for the first 4 hours that follow the dose.
After an overnight fast of ten to twelve (10-12) hours and in the morning of the second day of each study period (day 2), a standard high-fat breakfast (800-1000 calories) will be served to subjects, thirteen (30) minutes before dosing.
At 08:00 am, the study products will be administered orally in a randomized fashion with 240 ± 2 mL warm 20% glucose solution.
During each period of the study, 21 blood samples of 7 mL each will be collected (via an indwelling cannula into lithium heparin tubes) according to the following schedule: Pre dosing (zero time) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.5, 3.00, 3.50, 4.00, 4.5, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 \& 36.00 hours post dosing.
After collection, the blood samples will be placed in an ice bath or other chilling device until centrifugation.
Before each period of the study, 21 mL blood sample will be collected for bio-analytical purposes.
A blood sample of 3 mL may be needed for a possible control. Samples will be centrifuged at 4000 round per minute for 5 minutes at 10°C. Supernatant plasma will be transferred to pre-labeled polypropylene Eppendorf tubes and stored in freezers at nominal temperature of -20 C unless otherwise advised by the stability studies on samples.
Samples from all subjects will be analyzed at the bio-analytical site of the National Center of Pharmacovigilance according to validated in-house procedure using validated Liquid Chromatography-Mass Spectrometry Tandem method for the plasma concentrations of metformin \& vildagliptin.
Primary end points would be obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax, Air Under Cover (AUC) 0 - t \& AUC 0 - ∞.
Secondary end points would be obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Tmax, T half \& K elimination (λz).
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data of the following primary end points for metformin \& vildagliptin: Cmax, AUC 0 - t \& AUC 0 - ∞ and if there were no safety concerns and both products were well tolerated by the study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
| Arm | Type | Receives |
|---|---|---|
| First group of healthy volunteers | Experimental | Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®), Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)The first group of healthy volunteers, defined by randomization |
| Second group of healthy volunteers | Active comparator | Drug: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®), Drug: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)The second group of healthy volunteers, defined by randomization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- The subject is aged between eighteen to fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index (BMI) range (18.5 - 30.0 Kg/m2).
- The subject is able to understand and willing to sign the Informed Consent Form.
- The subject has completed his Coronavirus 19 vaccination schedule. E. The subject is willing to undergo the necessary medical examinations pre- during \& post-study.
- There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Key exclusion criteria (6 listed)
- The subject has suffered an acute illness within seven (7) days before dosing (declared after inclusion).
- The subject has been hospitalized during the study. C. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two (2) days before dosing and until 12 Hrs after dosing in both study periods.
- The subject has taken a prescription medication within two (2) weeks or even an OTC within seven (7) days before first dosing and any time during the study unless otherwise judged acceptable by the investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before dosing (declared after inclusion) and any time during the study.
- The subject underwent a radiological examination with an injection of Iodinated Contrast Media within 48 hours before first 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 |
|---|---|---|
| Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®)Also: Galvumet®The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg). | Drug | First group of healthy volunteers, Second group of healthy volunteers |
| Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)Also: BiGalvineThe subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg). | Drug | First group of healthy volunteers, Second group of healthy volunteers |
Primary outcome
Cmax
Time frame: 2 - 4 Hours
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax.
AUC 0 - t
Time frame: 0 - 24 Hours
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: AUC 0 - t.
3 secondary outcomes
Tmax
Time frame: 2 - 4 Hours
T half
Time frame: 7 days
K elimination (λz)
Time frame: 7 days
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 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Sameh Trabelsi principal investigator
Research Laboratory of Clinical and experimental Pharmacology LR16SP02
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 Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) and Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) in people with Fed Conditions, run by Reseach Laboratory of Clinical and Experimental Pharmacology at 1 site in Tunisia.
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 15 inclusion and 6 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 25 Oct 2023. 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 Tunisia. 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?
Cmax (time frame: 2 - 4 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 25 Oct 2023.