Skip to content

An Open-label, Single-dose, 3-Period Crossover Study to Evaluate the 2-way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects

An Open-label, Single-dose, 3-Period Crossover Study to Evaluate the 2-way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000582853
Enrollment
18
Registered
2012-05-30
Start date
2012-06-22
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

An Open-label, Single-Dose, 3-Period Crossover Study To Evaluate the 2-Way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is appropriate. However, this study is in healthy volunteers only.

Interventions

Treatment A: Sitagliptin 100mg (oral tablet) Treatment B: Losartan 100mg (oral tablet) Treatment C: Sitagliptin 100mg (oral tablet) + Losartan 100mg (oral tablet) Each participant receives each of the treatments (A, B, C) once as a single oral dose with a seven day wash-out period in between doses. The order in which they receive the treatments is randomized. MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is ap

Treatment A: Sitagliptin 100mg (oral tablet) Treatment B: Losartan 100mg (oral tablet) Treatment C: Sitagliptin 100mg (oral tablet) + Losartan 100mg (oral tablet) Each participant receives each of the treatments (A, B, C) once as a single oral dose with a seven day wash-out period in between doses. The order in which they receive the treatments is randomized. MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is appropriate. However, this study is in healthy volunteers only.

Sponsors

Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

-Subject judged to be in good health based on medical history, physical examination, ECG, vital sign measurements and laboratory safety tests -Non-smoker -BMI <30kg/m2

Exclusion criteria

-Mentally or legally incapacitated or having significant emotional problems or has a history of clinically significant psychiatric disorder -History of any clinically significant diseases/disorders, myopathic disorder or history of rhabdomyolysis. -Creatinine clearance <80mL/min -History of neoplastic disease -Pregnant, breast feeding or expecting to conceive -Major surgery or blood donation within 4 weeks -Consumes excessive amounts of alcohol or caffeine -History of significant allergies, anaphylactic reaction or significant intolerance to prescription/non-prescription drugs or food. -Regular/recreational drug user -History of hypersensitivity to sitagliptin, losartan or any of the tablet excipients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026