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Completed

NCT Number: NCT01068717

Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development, Lp

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women, aged 18 to 55 years, inclusive
  • Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
  • Body Mass Index of 18 to 32 kg/m^2, inclusive

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • History of allergy to DPP-4 inhibitors or related compounds
  • History of allergy or intolerance to metformin or other similar acting agents
  • Previous exposure to saxagliptin
  • Exposure to metformin within 3 months pervious to study drug administration
  • Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula

Treatment and study plan

Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)

Drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

Other names: Onglyza™, Glucophage™

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)

Drug

Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week

Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)

Drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

Other names: Onglyza™, Glucophage™

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)

Drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Primary outcomes

  1. Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  2. Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  3. Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  4. Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  5. AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  6. AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  7. AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

  8. Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

    Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

Secondary outcomes

  1. Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation

    Time frame: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4

    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

  2. Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results

    Time frame: At screening visit, at Day -1 of Periods 1 through 4, and at discharge

    Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.

  3. Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results

    Time frame: At screening visit, Day -1 of Period 1, and at study discharge

    Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.

  4. Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate

    Time frame: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.

    Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2010
Registry last updated
May 12, 2015

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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