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OpenTrials
Completed

NCT Number: NCT00842556

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)

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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–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development

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

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/[height(m)]2

Exclusion criteria

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
  • Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
  • History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
  • History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
  • Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
  • History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections

Treatment and study plan

Dapagliflozin

Drug

Tablets, Oral, 20 mg, Single Dose

Other names: BMS-512148

Glimepiride

Drug

Tablets, Oral, 4 mg, Single Dose

Other names: Amaryl

Sitagliptin

Drug

Tablets, Oral, 100 mg, Single Dose

Other names: Januvia

Primary outcomes

  1. Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs

    Time frame: 72 hours after dosing

Secondary outcomes

  1. To assess the safety and tolerability in healthy subjects

    Time frame: 15 time points up to 72 hours after dosing

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 12, 2009
Registry last updated
Oct 17, 2016

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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