Back to resultsThe Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
Primary Purpose
To Determine Bioequivalence Under Fed Conditions
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metformin and Vildagliptin 1000/50 mg
Sponsored by
About this trial
This is an interventional other trial for To Determine Bioequivalence Under Fed Conditions
Eligibility Criteria
Inclusion Criteria:
- Male subjects aged between 18 and 45 years (both inclusive).
- Subjects' weight within the normal range according to normal values for the Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- Subjects having negative alcohol breath test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- No history or presence of smoking.
- No history or presence of alcoholism and drug of abuse.
Exclusion Criteria:
- Hypersensitivity to Vildagliptin or Metformin or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.
- Major illness during 3 months before screening.
- Donation of blood in the past 3 months before screening.
- Participation in drug research study within past 3 months.
- Consumption of grapefruit juice within 72.00 hours prior to dosing in Period 01 and xanthine-containing products, tobacco containing products or alcohol within 48.00 hours prior to dosing in Period 01.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin and Vildagliptin 1000/50 mg Tablet
EUCREAS® 50/1000 mg Tablet
Arm Description
1 tablet of Metformin and Vildagliptin 1000/50 mg as single-dose administration
1 tablet of EUCREAS® 50/1000 mg (each film-coated tablet contains Vildagliptin 50 mg and Metformin hydrochloride 1000 mg) as single-dose administration
Outcomes
Primary Outcome Measures
Cmax of Vildagliptin and Metformin for the test and reference products
The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Secondary Outcome Measures
AUC0-∞ of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to to infinite time
Tmax of Vildagliptin and Metformin for the test and the reference products
The time to maximum measured plasma concentration
T1/2 of Vildagliptin and Metfomin for the test and the reference products
Plasma elimination half-life
Kel of Vildagliptin and Metformin for the test and the reference products
Elimination rate constant
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.
Full Information
NCT ID
NCT05329857
First Posted
March 25, 2022
Last Updated
April 14, 2022
Sponsor
AET Laboratories Private Limited
1. Study Identification
Unique Protocol Identification Number
NCT05329857
Brief Title
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
Official Title
Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AET Laboratories Private Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Determine Bioequivalence Under Fed Conditions
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin and Vildagliptin 1000/50 mg Tablet
Arm Type
Experimental
Arm Description
1 tablet of Metformin and Vildagliptin 1000/50 mg as single-dose administration
Arm Title
EUCREAS® 50/1000 mg Tablet
Arm Type
Active Comparator
Arm Description
1 tablet of EUCREAS® 50/1000 mg (each film-coated tablet contains Vildagliptin 50 mg and Metformin hydrochloride 1000 mg) as single-dose administration
Intervention Type
Drug
Intervention Name(s)
Metformin and Vildagliptin 1000/50 mg
Intervention Description
50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period
Primary Outcome Measure Information:
Title
Cmax of Vildagliptin and Metformin for the test and reference products
Description
The maximum concentration in plasma among observed concentrations at pre-specified time points
Time Frame
up to 24 hours
Title
AUC0-t of Vildagliptin and Metformin for the test and the reference products
Description
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
AUC0-∞ of Vildagliptin and Metformin for the test and the reference products
Description
The area under the plasma concentration versus time curve from time 0 to to infinite time
Time Frame
up to 24 hours
Title
Tmax of Vildagliptin and Metformin for the test and the reference products
Description
The time to maximum measured plasma concentration
Time Frame
up to 24 hours
Title
T1/2 of Vildagliptin and Metfomin for the test and the reference products
Description
Plasma elimination half-life
Time Frame
up to 24 hours
Title
Kel of Vildagliptin and Metformin for the test and the reference products
Description
Elimination rate constant
Time Frame
up to 24 hours
Title
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Description
An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male subjects aged between 18 and 45 years (both inclusive).
Subjects' weight within the normal range according to normal values for the Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
Subjects having clinically acceptable chest X-Ray (PA view).
Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
Subjects having negative alcohol breath test.
Subjects willing to adhere to the protocol requirements and to provide written informed consent.
No history or presence of smoking.
No history or presence of alcoholism and drug of abuse.
Exclusion Criteria:
Hypersensitivity to Vildagliptin or Metformin or related class of drugs.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
History or presence of asthma, urticaria or other significant allergic reactions.
History or presence of significant gastric and/or duodenal ulceration.
History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
History or presence of cancer or basal or squamous cell carcinoma.
Difficulty with donating blood.
Difficulty in swallowing solids like tablets or capsules.
Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.
Major illness during 3 months before screening.
Donation of blood in the past 3 months before screening.
Participation in drug research study within past 3 months.
Consumption of grapefruit juice within 72.00 hours prior to dosing in Period 01 and xanthine-containing products, tobacco containing products or alcohol within 48.00 hours prior to dosing in Period 01.
Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
History or presence of significant easy bruising or bleeding.
History or presence of significant recent trauma.
Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
12. IPD Sharing Statement
Learn more about this trial
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
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