Healthy Clinical Trial
Official title:
Bioequivalence Study of 160 mg Valsartan Film-coated Caplets Produced by PT Dexa Medica in Comparison With the Innovator Film-coated Tablets (Diovan® 160, Novartis Pharma AG)
Verified date | August 2015 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. Aged 18 - 55 years inclusive 3. Preferably non-smokers or smoke less than 10 cigarettes per day. 4. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) must be within the following ranges: - Systolic blood pressure : 110 - 120 mm Hg - Diastolic blood pressure : 70 - 80 mm Hg - Pulse rate : 60 - 90 bpm Exclusion Criteria: 1. Personal/family history of allergy or hypersensitivity or contraindication to valsartan or allied drugs. 2. Pregnant or lactating women (urinary pregnancy test will be applied to women subjects just before taking the study drug). 3. 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. 4. 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. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Clinically significant haematology abnormalities. 7. Clinically significant electrocardiogram (ECG) abnormalities. 8. 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. 9. Past history of anaphylaxis or angioedema. 10. History of drug or alcohol abuse within 12 months prior to screening for this study. 11. Participation in any clinical trial within the past 90 days calculated from the last visit. 12. History of any bleeding or coagulative disorders. 13. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm. 14. A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day. 15. Intake of any prescription or non-prescription drug, food supplement or herbal medicine within 14 days of this study's first dosing day. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month). | 1 months | Yes |
Primary | AUCt | Area under the curve of plasma concentrations versus time from time zero to the time of last observed quantifiable concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations) | 48 hours | No |
Primary | AUCinf | Area under the curve of plasma concentrations versus time from time zero to infinity was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations) | 48 hours | No |
Primary | Cmax | The maximum (peak) plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations) | 48 hours | No |
Secondary | Tmax | The time of peak plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations) | 48 hours | No |
Secondary | T1/2 | The elimination half-life was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations) | 48 hours | No |
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