BioequivalencePhase 1NCT05549570
Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers
A Phase 1 study testing Sitagliptin/Metformin HCl 50/850 mg film-coated tablet in people with Bioequivalence and Diabetes Mellitus, Type 2, run by Galenicum Health at 1 site in Canada.
Trial summary
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Diabetes Mellitus, Type 2
- What is being tested?
- Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2017to 1 Nov 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Females who were pregnant or were lactating
- History of significant hypersensitivity to metformin, sitagliptin or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- History of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Show all 19Show fewer
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >119 msec and QTc > 450 msec for males and QTc > 460 for females) on the screening ECG or other clinically significant ECG abnormalities
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests
- Females who were pregnant according to a positive pregnancy test
- Volunteers who took metformin and/or sitagliptin in the previous 28 days before day 1 of this study
- Volunteers who took an Investigational Product (in another clinical trial) in the previous 28 days before day 1 of this study
- Volunteers who had already participated in this clinical study
- Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Film-coated Tablets in Healthy Male and Female Volunteers.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions.
- Conditions
- Bioequivalence, Diabetes Mellitus, Type 2
- Being tested
- Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin/Metformin HCl 50/850 mg film-coated tabletDrug
The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Experimental | Thirty minutes after the start of the breakfast, a single dose of the Reference formulation was administered with approximately 240 mL of water at ambient temperature Receives: Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tablet |
| Test group | Experimental | Thirty minutes after the start of the breakfast, a single dose of the Test formulation was administered with approximately 240 mL of water at ambient temperature Receives: Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC) 0-t
Evaluation of plasma concentration-time curve from zero to the time of the last measurable time point t
Measured: 48 hours
Secondary outcomes (1)
Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia.
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 20.1 (Medrio database) and graded as mild, moderate, or severe.
The principal investigator or qualified designee determined the relationship of any AE to the investigational product.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start22 Oct 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galenicum Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549570
- Sponsor's protocol ID
- GLU-P6-810
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnaars Y, Gaikwad S, Gottwald-Hostalek U, Uhl W, Ribot O, Varanasi KVS, Rodriguez L, Torrejon J, Gomez L. Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin-Metformin Fixed-Dose Combination Compared with the Originator Products. Diabetes Ther. 2023 Feb;14(2):347-362. doi: 10.1007/s13300-022-01349-2. Epub 2022 Dec 16.
PubMed 36526947
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Crossover Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Film-coated Tablets in Healthy Male and Female Volunteers.
- ClinicalTrials.gov ID
- NCT05549570
- Acronym / sponsor ID
- GLU-P6-810
- Conditions
- Bioequivalence, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Galenicum HealthIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 22 Sep 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.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference group | Experimental | Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tabletThirty minutes after the start of the breakfast, a single dose of the Reference formulation was administered with approximately 240 mL of water at ambient temperature |
| Test group | Experimental | Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tabletThirty minutes after the start of the breakfast, a single dose of the Test formulation was administered with approximately 240 mL of water at ambient temperature |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Females who were pregnant or were lactating
- History of significant hypersensitivity to metformin, sitagliptin or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
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 |
|---|---|---|
| Sitagliptin/Metformin HCl 50/850 mg film-coated tabletThe subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet | Drug | Reference group, Test group |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 48 hours
Evaluation of plasma concentration-time curve from zero to the time of the last measurable time point t
1 secondary outcome
Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia.
Time frame: 1 week
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 Sep 2022.
- Derived from this study: PubMed 36526947Schnaars Y, Gaikwad S, Gottwald-Hostalek U, Uhl W, Ribot O, Varanasi KVS, Rodriguez L, Torrejon J, Gomez L. Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin-Metformin Fixed-Dose Combination Compared with the Originator Products. Diabetes Ther. 2023 Feb;14(2):347-362. doi: 10.1007/s13300-022-01349-2. Epub 2022 Dec 16.
- 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.
Eric Sicard principal investigator
Algorithme Pharma Inc
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 Sitagliptin/Metformin HCl 50/850 mg film-coated tablet in people with Bioequivalence and Diabetes Mellitus, Type 2, run by Galenicum Health at 1 site in Canada.
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 0 inclusion and 19 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 Sep 2022. 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 Canada. 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?
Peak Plasma Concentration (Cmax) (time frame: 48 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?
On the ClinicalTrials.gov record for NCT05549570, which also lists 1 linked publication.
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 Sep 2022.