Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg (NCT02518451) | Clinical Trial Compass
CompletedNot Applicable
Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
Indonesia48 participantsStarted 2013-06
Plain-language summary
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
✓. Aged 18 - 55 years inclusive
✓. Preferably non-smokers or smoke less than 10 cigarettes per day.
✓. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
✓. Body mass index within 18 to 25 kg/m2.
✓. Vital signs (after 10 minutes rest) must be within the following ranges:
Exclusion criteria
✕. Personal/family history of allergy or hypersensitivity or contraindication to valsartan or allied drugs.
✕. Pregnant or lactating women (urinary pregnancy test will be applied to women subjects just before taking the study drug).
✕. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, hypotensive episodes, hyperglycemia, etc.
✕. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin \>= 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL), etc.
✕. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
✕. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery.