Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770302

Enrollment

Registered

2008-10-09

Start date

2008-10-31

Completion date

2008-10-31

Last updated

2009-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

DPP-4 inhibitors, HBA1c, Incretins, Pharmacokinetics

Brief summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.

Interventions

DRUGSaxagliptin

Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Men or women (not of childbearing potential) of Chinese ethnicity * Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2 * Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion criteria

* History of clinically significant hypoglycaemia (low blood sugar levels) * Women who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin	Multiple timepoints during 9 days

Secondary

Measure	Time frame
Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin	Multiple time points during 9 days
Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin	Multiple time points during 10 days (including measurements before dosing)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026