HealthyPhase 1ABSVAFVATVATNCT04085627
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)
A Phase 1 study testing Valsartan and Amlodipine Tablets in people with Healthy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valsartan and Amlodipine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 26 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subjects may not be able to complete this study or other researchers ' judgment for other reasons. Note: the exclusion criteria in 1th, 2, 3, 4, 6, 9 in the time are from the first 1 days before the administration of the Calculation.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou, Zhejiang, 325000
About this study
Official title: Comparative Open-label,Randomized, Fasting/Fed, Single Dose, Three-way Crossover Bioequivalence Study of Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)
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).
Read the 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
- Being tested
- Valsartan and Amlodipine Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan and Amlodipine TabletsDrug
1 tablet contains Valsartan 80mg\& Amlodipine 5mg
| Study group | Role | What they receive |
|---|---|---|
| T Test | Experimental | Test drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg Receives: Drug: Valsartan and Amlodipine Tablets |
| R Reference | Active comparator | Reference drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg Receives: Drug: Valsartan and Amlodipine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax
Measured: Up to 96 hours post dose in each treatment period
Bioequivalence based on AUC parameters
Measured: Up to 96 hours post dose in each treatment period
Secondary outcomes (6)
Number of subjects with adverse events (AE)s
Safety and tolerability parameters will include recording of AEs(blood biochemistry, urine routine examination, electrocardiograph, etc.)
Measured: Up to 96 hours post dose in each treatment period
blood pressure
Vital sign measurement will include blood pressure
Measured: Up to 96 hours post dose in each treatment period
pulse rate
Vital sign measurement will include pulse rate
Measured: Up to 96 hours post dose in each treatment period
respiration rate
Vital sign measurement will include respiration rate
Measured: Up to 96 hours post dose in each treatment period
ear temperature
Vital sign measurement will include ear temperature
Measured: Up to 96 hours post dose in each treatment period
complete blood count
Clinical laboratory tests will include CBC
Measured: Up to 96 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start8 Oct 2018
- Primary completion28 Nov 2018
- Study completion26 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085627
- Sponsor's protocol ID
- 2018-10-17
- Acronym
- ABSVAFVATVAT
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Open-label,Randomized, Fasting/Fed, Single Dose, Three-way Crossover Bioequivalence Study of Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)
- ClinicalTrials.gov ID
- NCT04085627
- Acronym / sponsor ID
- ABSVAFVATVAT / 2018-10-17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 26 Dec 2019 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T Test | Experimental | Drug: Valsartan and Amlodipine TabletsTest drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg |
| R Reference | Active comparator | Drug: Valsartan and Amlodipine TabletsReference drug(Valsartan / Amlodipine)1 tablet contains Valsartan 80mg\& Amlodipine 5mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan and Amlodipine Tablets1 tablet contains Valsartan 80mg\& Amlodipine 5mg | Drug | R Reference, T Test |
Primary outcome
Bioequivalence based on Cmax
Time frame: Up to 96 hours post dose in each treatment period
Bioequivalence based on AUC parameters
Time frame: Up to 96 hours post dose in each treatment period
6 secondary outcomes
Number of subjects with adverse events (AE)s
Time frame: Up to 96 hours post dose in each treatment period
blood pressure
Time frame: Up to 96 hours post dose in each treatment period
pulse rate
Time frame: Up to 96 hours post dose in each treatment period
respiration rate
Time frame: Up to 96 hours post dose in each treatment period
ear temperature
Time frame: Up to 96 hours post dose in each treatment period
complete blood count
Time frame: Up to 96 hours post dose in each treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valsartan and Amlodipine Tablets in people with Healthy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax (time frame: Up to 96 hours post dose in each treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.