Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02518451
• Date of registration: 03/08/2015
• Prospective Registration: No
• Primary sponsor: Dexa Medica Group
• Public title: Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
• Scientific 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)
• Date of first enrolment: June 2013
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02518451
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Effi Setiawati, MSc
• Affiliation: PT Equilab International

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Valsartan 160 mg film-coated caplets (test formulation)

Drug: Valsartan 160 mg film-coated caplets (reference formulation)

Primary Outcome(s)

AUCinf [Time Frame: 48 hours]

Cmax [Time Frame: 48 hours]

AUCt [Time Frame: 48 hours]

Secondary Outcome(s)

T1/2 [Time Frame: 48 hours]

Tmax [Time Frame: 48 hours]

Secondary ID(s)

PR. 183/EQL/2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors