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OpenTrials
Completed

NCT Number: NCT05337969

The Study Aims 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 Assessed.

To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/850mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin and Vildagliptin 850/50 mg

Drug

50 mg Vildagliptin + 850 mg Metformin as single-dose per study period

Primary outcomes

  1. Cmax of Vildagliptin and Metformin for the test and reference products

    Time frame: up to 24 hours

    The maximum concentration in plasma among observed concentrations at pre-specified time points

  2. AUC0-t of Vildagliptin and Metformin for the test and the reference products

    Time frame: up to 24 hours

    The area under the plasma concentration versus time curve from time 0 to the last measured concentration

Secondary outcomes

  1. AUC0-∞ of Vildagliptin and Metformin for the test and the reference products

    Time frame: up to 24 hours

    The area under the plasma concentration versus time curve from time 0 to to infinite time

  2. Tmax of Vildagliptin and Metformin for the test and the reference products

    Time frame: up to 24 hours

    The time to maximum measured plasma concentration

  3. T1/2 of Vildagliptin and Metfomin for the test and the reference products

    Time frame: up to 24 hours

    Plasma elimination half-life

  4. Kel of Vildagliptin and Metformin for the test and the reference products

    Time frame: up to 24 hours

    Elimination rate constant

  5. Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol

    Time frame: through study completion, an average of 1 month

    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.

Sponsors and collaborators

Lead sponsor

AET Laboratories Private Limited

Industry

Registry information

Official study title

Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 850/ 50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/850mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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