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)

NCT04085627 | Unknown Phase 1 DMC

• 1 other identifier: 2018-10-17
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax

  Up to 96 hours post dose in each treatment period

• Bioequivalence based on AUC parameters

  Up to 96 hours post dose in each treatment period

Secondary Outcomes (6)

• Number of subjects with adverse events (AE)s

  Up to 96 hours post dose in each treatment period

• blood pressure

  Up to 96 hours post dose in each treatment period

• pulse rate

  Up to 96 hours post dose in each treatment period

• respiration rate

  Up to 96 hours post dose in each treatment period

• ear temperature

  Up to 96 hours post dose in each treatment period

Study Arms (2)

T Test

EXPERIMENTAL

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

Drug: Valsartan and Amlodipine Tablets

R Reference

ACTIVE COMPARATOR

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

Drug: Valsartan and Amlodipine Tablets

Interventions

Valsartan and Amlodipine Tablets DRUG

1 tablet contains Valsartan 80mg\& Amlodipine 5mg

R Reference; T Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Valsartan; Amlodipine

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: September 11, 2019
• Study Start: October 8, 2018
• Primary Completion: November 28, 2018
• Study Completion: December 26, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)