BioequivalencePhase 1NCT05549583
Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers
A Phase 1 study testing Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet in people with Bioequivalence and Type 2 Diabetes, run by Galenicum Health at 1 site in Canada.
Trial summary
The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin 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, Type 2 Diabetes
- What is being tested?
- Sitagliptin/metformin hydrochloride (HCl) 50/1000 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
- 15 Apr 2018to 25 Apr 2018
- 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 lactating at screening
- Females who were pregnant according to the pregnancy test at screening or prior to the first study drug administration
- History of significant hypersensitivity to sitagliptin, metformin 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 condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Show all 18Show fewer
- Presence of out-of-range cardiac interval (PR <110 msec, PR >200 msec, QRS<60 msec, QRS >110 msec and QTc >440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator
- 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 28 days prior to the first study drug administration
- Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would have put into question the status of the volunteer as healthy
- Any history of tuberculosis or proven contact with tuberculosis
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG [B] [hepatitis B]) or Hepatitis C Virus (HCV [C]) tests
- Volunteers who had already been included in a previous group for this clinical study
- Volunteers who took sitagliptin and/or metformin in the 28 days prior to the first study drug administration
- Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration
- Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Film-coated Tablets in Healthy Male and Female Volunteers / Fed State
The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.
- Conditions
- Bioequivalence, Type 2 Diabetes
- Being tested
- Sitagliptin/metformin hydrochloride (HCl) 50/1000 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 hydrochloride (HCl) 50/1000 mg film-coated tabletDrug
The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 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 hydrochloride (HCl) 50/1000 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 hydrochloride (HCl) 50/1000 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 start15 Apr 2018
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
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
- NCT05549583
- Sponsor's protocol ID
- GLU-P6-327
- 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 Sitagliptin/Metformin 50 mg/1000 mg Film-coated Tablets in Healthy Male and Female Volunteers / Fed State
- ClinicalTrials.gov ID
- NCT05549583
- Acronym / sponsor ID
- GLU-P6-327
- Conditions
- Bioequivalence, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Galenicum HealthIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (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 determine the bioequivalence of two different formulations of sitagliptin/ metformin 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 hydrochloride (HCl) 50/1000 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 hydrochloride (HCl) 50/1000 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 (18 listed)
- Females who were lactating at screening
- Females who were pregnant according to the pregnancy test at screening or prior to the first study drug administration
- History of significant hypersensitivity to sitagliptin, metformin 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 condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
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 hydrochloride (HCl) 50/1000 mg film-coated tabletThe subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 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 hydrochloride (HCl) 50/1000 mg film-coated tablet in people with Bioequivalence and Type 2 Diabetes, 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 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 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 NCT05549583, 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.