Bioequivalence Study in Healthy SubjectsACL24-PC020NCT07633041
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets Under Fed Conditions.
A study testing Synjardy 12.5/1000 mg tablet and Empagliflozin/metformin 12.5/1000 mg in people with Bioequivalence Study in Healthy Subjects, run by ADIUM at 1 site in Mexico.
Trial summary
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- Synjardy 12.5/1000 mg tablet and Empagliflozin/metformin 12.5/1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 5 Feb 2025to 4 Apr 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55 years.
- Clinically healthy according to the updated medical history prior to the start of the study.
- Not blocked in the COFEPRIS research subject database.
- Body mass index between 18 and 27 kg/m².
- Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C.
- Electrocardiogram (ECG) without any signs of pathology.
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- Clinical laboratory test results within normal limits or with clinically insignificant variations.
- Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL).
- Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC).
- Negative qualitative pregnancy test (for women).
- Negative breath alcohol test.
- Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use.
- Subjects with a signed informed consent form and a signed non-pregnancy commitment letter.
- Women who are not pregnant or breastfeeding.
- Women using at least one method of family planning deemed safe by the principal investigator.
Who cannot join
- Subjects with a history of hypersensitivity to the study drug.
- Subjects with lactose intolerance.
- Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product.
- Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug.
- Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study.
- Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions."
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- Subjects who have been hospitalized for any reason within sixty days prior to the start of the study or who have been seriously ill within thirty days prior to the start of the study.
- Subjects who have received an investigational drug within ninety days prior to the start of the study.
- Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study.
- Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use.
- Subjects who have consumed beverages or foods containing xanthines (coffee, tea, cocoa, chocolate, yerba mate, cola, etc.) or have consumed charcoal-grilled foods within 12 hours prior to administration of the medication dose.
- Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study.
- Subjects who have smoked at least 12 hours before the start of the study.
- Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose.
- Positive (qualitative) pregnancy test.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Axis Clinicals Latina, S.A. de C.V.
Mexico City, Mexico City, 07870
About this study
Official title: Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets in Healthy Subjects Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
Read the detailed description
The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 14-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 12.5/ 1000 mg empagliflozin/metformin FDC tablet in forty-two (42) healthy Mexican adult volunteers aged 18 to 55 years.
- Conditions
- Bioequivalence Study in Healthy Subjects
- Being tested
- Synjardy 12.5/1000 mg tablet, Empagliflozin/metformin 12.5/1000 mg
- Keywords
- empagliflozin, metformin, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synjardy 12.5/1000 mg tabletDrug
Reference
Empagliflozin/metformin 12.5/1000 mgDrug
Test
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Synjardy 12.5/1000 mg tablet, Reference Receives: Drug: Synjardy 12.5/1000 mg tablet |
| Test | Experimental | Empagliflozin/metformin 12.5/1000 mg test Receives: Drug: Empagliflozin/metformin 12.5/1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on the pharmacokinetic parameter: Cmax
Bioequivalence based on the pharmacokinetic parameter: Cmax
Measured: Through 48 Hours Post Dose
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
Measured: Through 48 Hours Post Dose
Secondary outcomes (5)
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)
Measured: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: elimination constant (Ke)
Characterize the pharmacokinetic parameter: elimination constant (Ke)
Measured: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: half-life (t1/2)
Characterize the pharmacokinetic parameter: half-life (t1/2)
Measured: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: AUC0-inf
Characterize the pharmacokinetic parameter: AUC0-inf
Measured: Through 48 Hours Post Dose
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.
Measured: Until the final visit (14 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start5 Feb 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
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 Bioequivalence Study in Healthy SubjectsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633041
- Sponsor's protocol ID
- ACL24-PC020
- Acronym
- ACL24-PC020
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, the clinical research site will provide this data with prior authorization from the sponsor, without disclosing personal information. All information will be uniquely identified by the research subject's initials and/or their assigned randomization number, thus guaranteeing their privacy.
Publications
Guido Avila EG, Martinez Munoz A, de la Cruz Cruz P, Hernandez Pina OE, Perez-Urizar JT, Escobedo-Moratilla A. Bioequivalence Evaluation of Immediate-Release Empagliflozin/Metformin Fixed-Dose Combination Tablets Under Fed Conditions in Healthy Mexican Subjects and Exploratory Analysis of Metformin Dose Proportionality. Pharmaceuticals (Basel). 2026 Jul 31;19(8):1200. doi: 10.3390/ph19081200.
PubMed 42653697
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets in Healthy Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT07633041
- Acronym / sponsor ID
- ACL24-PC020 / ACL24-PC020
- Conditions
- Bioequivalence Study in Healthy Subjects
- Keywords
- empagliflozin, metformin, bioequivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ADIUMIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 8 Jun 2026 (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.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
Detailed description
The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 14-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 12.5/ 1000 mg empagliflozin/metformin FDC tablet in forty-two (42) healthy Mexican adult volunteers aged 18 to 55 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Drug: Synjardy 12.5/1000 mg tabletSynjardy 12.5/1000 mg tablet, Reference |
| Test | Experimental | Drug: Empagliflozin/metformin 12.5/1000 mgEmpagliflozin/metformin 12.5/1000 mg test |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age between 18 and 55 years.
- Clinically healthy according to the updated medical history prior to the start of the study.
- Not blocked in the COFEPRIS research subject database.
- Body mass index between 18 and 27 kg/m².
- Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C.
Key exclusion criteria (15 listed)
- Subjects with a history of hypersensitivity to the study drug.
- Subjects with lactose intolerance.
- Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product.
- Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug.
- Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study.
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 |
|---|---|---|
| Synjardy 12.5/1000 mg tabletReference | Drug | Reference |
| Empagliflozin/metformin 12.5/1000 mgTest | Drug | Test |
Primary outcome
Bioequivalence based on the pharmacokinetic parameter: Cmax
Time frame: Through 48 Hours Post Dose
Bioequivalence based on the pharmacokinetic parameter: Cmax
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
Time frame: Through 48 Hours Post Dose
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
5 secondary outcomes
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: elimination constant (Ke)
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: half-life (t1/2)
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: AUC0-inf
Time frame: Through 48 Hours Post Dose
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.
Time frame: Until the final visit (14 days after the last dose)
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 10 Jun 2026.
- Derived from this study: PubMed 42653697Guido Avila EG, Martinez Munoz A, de la Cruz Cruz P, Hernandez Pina OE, Perez-Urizar JT, Escobedo-Moratilla A. Bioequivalence Evaluation of Immediate-Release Empagliflozin/Metformin Fixed-Dose Combination Tablets Under Fed Conditions in Healthy Mexican Subjects and Exploratory Analysis of Metformin Dose Proportionality. Pharmaceuticals (Basel). 2026 Jul 31;19(8):1200. doi: 10.3390/ph19081200.
- Individual participant dataSharing planned: Yes. Upon request, the clinical research site will provide this data with prior authorization from the sponsor, without disclosing personal information. All information will be uniquely identified by the research subject's initials and/or their assigned randomization number, thus guaranteeing their privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synjardy 12.5/1000 mg tablet and Empagliflozin/metformin 12.5/1000 mg in people with Bioequivalence Study in Healthy Subjects, run by ADIUM at 1 site in Mexico.
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 15 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 10 Jun 2026. 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 Mexico. 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.
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?
Bioequivalence based on the pharmacokinetic parameter: Cmax (time frame: Through 48 Hours Post Dose). 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 NCT07633041, 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 10 Jun 2026.