A Bioequivalence Study of Valsartan / Amlodipine From Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)

NCT ID: NCT04085627

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2019-12-26

Brief Summary

Comparative randomized, single dose, three periods, three-way crossover open-label study to determine the bioequivalence of Valsartan and Amlodipine Tablets (Hua yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland).

Detailed Description

Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) .Secondary Pharmacokinetic Parameters: tmax and t1/2. The method of judging bioequivalence of three-cross-section repeating experiment design: first of all, the calculation of the SWR of the AUC and Cmax, if SWR≥0.294, the use of RSABE analysis; if Swr<0.294, the average Bioequivalence analysis method with Non-scale (bioequivalence limit is 80%~125 %）.

A comprehensive final report will be issued upon the completion of the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

T Test

Test drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg

Group Type: EXPERIMENTAL

Valsartan and Amlodipine Tablets

Intervention Type: DRUG

1 tablet contains Valsartan 80mg\& Amlodipine 5mg

R Reference

Reference drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg

Group Type: ACTIVE_COMPARATOR

Valsartan and Amlodipine Tablets

Intervention Type: DRUG

1 tablet contains Valsartan 80mg\& Amlodipine 5mg

Interventions

Valsartan and Amlodipine Tablets

1 tablet contains Valsartan 80mg\& Amlodipine 5mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male or non-pregnant non-lactating female, age 18 to 45 years, including the critical value.
• Male weight ≥ 50kg, female weight ≥ 45kg, body mass index (BMI) between 19 and 28kg / m2, including the critical value.
• Good health, no heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disease history.
• Sign informed consent prior to the test and fully understand the contents, process and possible adverse reactions, and be able to communicate well with the researcher.

Exclusion Criteria

• Any clinical trials in the 90 days prior to the trial, or other clinical trials planned for the duration of the trial.
• Underwent major surgery within 90 days of the trial or planned to undergo surgery within 3 months of the trial.
• Blood loss or blood donation over 300mL in the 90 days before the test.
• Esophageal reflux, stomach bleeding or peptic ulcer disease in the 180 days prior to the test, heartburn occurs more than once a week, or any surgical procedure that may affect drug absorption (E.G. cholecystectomy).
• Persons with specific allergies (asthma, urticaria, eczema, etc.) or allergies (such as those who are allergic to two or more medications, food or pollen), or are known to be allergic to the ingredients * or analogues of the drug.

• The main components of the trial preparation: valsartan, benzene sulfonic acid amlodipine, microcrystalline cellulose, crosslinked povidone, crosslinked carboxymethyl cellulose sodium, silica, magnesium stearate, hydroxypropyl methyl cellulose, iron oxide yellow, polyethylene glycol, talc, Titanium dioxide; Reference Preparation main components: valsartan, amlodipine, microcrystalline cellulose, cross-linked povidone, silica, Magnesium stearate, hydroxypropyl methyl cellulose, iron oxide yellow, polyethylene glycol, talcum powder, Titanium Dioxide.
• Use of any medication within 28 days of the trial, including prescription, over- the-counter, and/or alternative medications (such as medicinal herbs, herbal medicines, hemostasis and blood-activating plants or health supplements), and the use of hormonal contraceptives or vaccines.
• A history of psychotropic substance abuse.
• Urine screening Positive.
• The average daily smoking was over 3 in the 90 days prior to the trial, alcohol consumption, women drinking more than 7 cups per week for 28 days or more than 14 cups per week for men (1 cups of =150ml wine =360ml Beer =45ml spirits).
• Alcohol expiratory test Positive.
• Body temperature (ear Temperature) ≥37.5℃, breathing is obviously abnormal and the researchers believe that it is not suitable to participate in the test, sitting systolic pressure >140mmhg or <100mmhg, sitting diastolic pressure >90mmhg or <60mmhg, sitting pulse 50 times/minute or > 100 Times/minute.
• Human immunodeficiency virus antibody (HIV-Ab), hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) or Treponema pallidum antibody (TP) Positive.
• Special dietary requirements, No uniform diet during the trial.
• Subjects refused to comply with the drug before 48h banned caffeine, alcohol, grapefruit beverages and food (including tea, chocolate, coffee, coke, etc.).
• Participants with a companion refused to use effective contraceptive measures within 180 days of screening to the completion of the test, as detailed in Appendix 2.
• Female subjects were tested positive for blood/urine pregnancy.
• Persons with impaired renal function, or who have suffered from urinary system disease.
• A History of orthostatic hypotension.
• fainting during venipuncture, dizzy blood and venous blood collection difficult person.
• The physical examination was obviously abnormal and the researchers found it inappropriate to participate in the trial.
• There was a significant abnormality in the ECG test and the researchers found it inappropriate to Participate.
• Blood biochemistry, blood routine, urine routine examination had the obvious abnormality and the researcher thought that was not suitable to participate in the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

Wenzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2018-10-17

Identifier Type: -

Identifier Source: org_study_id