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Completed

NCT Number: NCT01365091

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both 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

Local Institution

Campinas, São Paulo, 13073, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy men and women
  • women of childbearing potential who are using acceptable method of contraception
  • Women who are not pregnant or nursing
  • Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.

Key Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • History of gastrointestinal (GI) disease
  • Major surgery within 4 weeks of study drug administration
  • Any GI surgery that could impact study drug absorption
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
  • Blood transfusion within 3 months of study drug administration for women and within 2 months for men
  • Inability to be venipunctured and/or tolerate venous access
  • Current smoker or recent (within 1 month) history of regular tobacco use
  • Recent (within 6 months of study drug administration) drug or alcohol abuse
  • Participation in a bioequivalence study within the last 6 months of study drug administration
  • Estimated creatinine clearance of <80 mL/min using Cockcroft-Gault formula
  • History of allergy to drug class or related compounds
  • History of allergy to metformin or other similar acting agents
  • History of any significant drug allergy

Treatment and study plan

Saxagliptin/metformin fixed-dose combination (FDC)

Drug

Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

Other names: Onglyza/Glucophage extended release (XR)

Saxagliptin

Drug

Tablet, oral, 5 mg, once on Day 1 only, 1 day

Other names: Onglyza

Metformin extended-release (XR)

Drug

Tablet, oral, 500 mg, once on Day 1 only, 1 day

Other names: Glifage XR

Saxagliptin/Metformin FDC

Drug

Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

Other names: Onglyza/Glucophage XR

metformin

Drug

Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Other names: Glifage XR

Primary outcomes

  1. Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

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

  2. AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

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

    AUC=Area under the concentration-time curve

  3. AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

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

    AUC=Area Under the Concentration-time Curve

Secondary outcomes

  1. Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)

    Time frame: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1

    SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
May 8, 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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