An open-labeled, randomized, single-dose, 2-period, 2-treatment, 2-way crossover bioequivalence study of Valsartan/Amlodipine 160/10 mg in male and female subjects under fasting conditions.
- Conditions
- Bioequivalence study in healthy volunteers
- Registration Number
- TCTR20170225001
- Lead Sponsor
- Bio-innova and Synchron Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
1.Willingness to provide written informed consent prior to participation in the study.
2.Healthy Thai subjects are between 18 to 55 years of age.
3.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2.
4.Comprehensive of the nature and purpose of the study and in compliance with the requirements of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects’ safety after the completion of the study.
5.Negative urine pregnancy test and no breast-feeding.
6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
1.History or evidence of allergy or hypersensitivity to Valsartan or Amlodipine or any related drugs or any of the excipients of this product.
2.Reports a history of clinically significant allergies including food or drug allergies.
3.Difficulty in swallowing solids like tablets or capsules.
4.Subjects having positive urine cotinine analysis test.
5.Subject with B.P. is Systolic B.P < 90, ≥140 mm/Hg, Diastolic B.P < 60, ≥90 mm/Hg or pulse rate > 100 beats per minute.
6.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
7.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR). *
8.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
9.Positive of hepatitis B or C virus or HIV.
10.Have more than one abnormal EKG, which is considered as clinically significant.*
11.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, or glaucoma.
12.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
13.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
14.History of psychiatric disorder.
15.History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
16.History of usually smoking (more than 10 cigarettes per day), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
17.High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
18.Banana or citrus fruit or grape fruit or its products consumption and cannot stop at least 7 days before the study drug administration and until the completion of the study.
19.Positive drug abuse test in urine (Marijuana (THC), Cocaine, Opioids, Amphetamine, Benzodiazepines, Barbiturates).
20.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera® must be discontinued at least 6 months) prior to receiving the first dose of study medication.
21.History or difficulty in accessibility of veins in left or right arm.
22.Blood donation (one unit or 350 mL) within the past 3 months before the study.
23.Participation in any clinical study within the past 3 months before the study.
24.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioequivalence study for valsartan at pre-dose (0.0 hour) and at 0.5, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 5.5, 6.0, 6.5, pharmacokinetic parameter
- Secondary Outcome Measures
Name Time Method safety 1.0, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 24.0, 36.0, 48.0 and 72.0 Safety monitoring