Healthy VolunteerPhase 1NCT06193044
Bioequivalence Study of Amlodipine/Valsartan 10/160 mg Film Coated Tablets
A Phase 1 study testing Amlodipine/Valsartan and Amlodipine 10 mg &valsartan 160 mg (Exforge) in people with Healthy Volunteer, run by International Bio service.
Trial summary
Comparative randomized, Single dose, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Amlodipine/Valsartan and Amlodipine 10 mg &valsartan 160 mg (Exforge)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2024to 12 Jul 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-smoker and non-consumer of nicotine containing products Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 14 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
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- Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 14 days after the end of study in Period 4.
- Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
- Adequate venous access in both arms for the collection of a number of samples during the study
Who cannot join
- History of allergic reaction or hypersensitivity to simvastatin or to any excipients of tablet
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/ hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of coronavirus disease starting in 2019 (COVID-19)
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period
- History of problems with swallowing tablet or capsule
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- History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- History of diarrhea or vomiting within 24 hours prior to check-in in each period
- 12-lead ECG demonstrating corrected QT interval (QTc) >450 msec, a QRS Complex (QRS interval) >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
- Investigation with blood sample shows positive test for HBsAg.
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- History or evidence of liver disease or renal impairment
- Creatine kinase (CK) levels > 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test.
- Have epidermal growth factor receptor(eGFR) (CKD-EPI) <30 mL/ min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment
- Abnormal liver function, ≥1.5 times of upper normal limit of reference range for Alanine Transaminase (ALT), Aspartate transaminase (AST) or bilirubin levels at screening laboratory test
- History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
- History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.)
- History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result. In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% Blood alcohol concentration (BAC) and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC.
- History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
- History or evidence of strenuous exercise and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study.
- Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to check-in in Period 1 and continued for entire duration of the study
- Use of prescription or nonprescription drugs (e.g. paracetamol, potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, erythromycin, clarithromycin), HIV protease inhibitors (e.g. nelfinavir), cyclosporine, statins, fibrates, gemfibrozil, daptomycin, niacin, fusidic acid etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study
- Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study
- Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment
- Subjects with poor venous access or intolerant to venipuncture
- Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team
- Subjects who are employees of International Bio Service Co., Ltd. or sponsor
- Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study.
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Amlodipine and Valsartan Tablets 10/160 mg and Reference Product (Exforge® 10/160 mg Tablets)
Comparative randomized, Single dose, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA).
Read the detailed description
The primary objective of this bioequivalence study is to assess and compare the rate and extent of absorption of a test formulation against a reference formulation, with an additional focus on evaluating the safety profiles of both formulations. This study aims to provide critical insights into the bioequivalence of the two formulations, shedding light on their pharmacokinetic parameters and overall safety in the context of therapeutic efficacy.
Study Design:
The study adopts an Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study design to ensure robustness and reliability in the evaluation of bioequivalence. The Replicate Crossover design minimizes the impact of inter-individual variability, allowing for a more accurate assessment of the formulations' performance.
Participant Selection:
A total of 48 healthy Thai volunteers will be recruited to participate in the study. The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements. The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison, ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation.
Study Conditions:
The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables. Fasting conditions provide a controlled environment to evaluate the formulations' performance and allow for a more accurate determination of bioequivalence.
- Conditions
- Healthy Volunteer
- Being tested
- Amlodipine/Valsartan, Amlodipine 10 mg &valsartan 160 mg (Exforge)
- Keywords
- Amlodipine, Valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/ValsartanDrug
Also called Amlodipine / Valsartan
Amlodipine 10 mg \&valsartan 160 mg
Amlodipine 10 mg &valsartan 160 mg (Exforge)Drug
Also called Exforge
Amlodipine 10 mg \&valsartan 160 mg
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg | Experimental | Participants first received Amlodipine and Valsartan Tablet USP 10/160 mg 1 tablet (Test product) in a fasting state.After a washout period of 21 days, they then recieved Exforge® 10/160 mg tablet (Reference product) in a fasting state Receives: Drug: Amlodipine/Valsartan; Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge) |
| Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg | Active comparator | Participants first received Exforge® 10/160 mg tablet 1 tablet (Reference product) in a fasting state.After a washout period of 21 days, they then recieved Amlodipine and Valsartan Tablets USP 10/160 mg (Test product) in a fasting state. Receives: Drug: Amlodipine/Valsartan; Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax period
Bioequivalence based on Cmax period
Measured: Up to 72 hours post dose in each treatment
Bioequivalence based on AUC parameters
Bioequivalence based on AUC parameters
Measured: Up to 72 hours post dose in each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start7 May 2024 (estimated)
- Primary completion9 Jul 2024 (estimated)
- Study completion12 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- 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
- Model description
- (Reference Replicate)
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Bio service
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Prof., Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193044
- Sponsor's protocol ID
- BE22-041
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Amlodipine and Valsartan Tablets 10/160 mg and Reference Product (Exforge® 10/160 mg Tablets)
- ClinicalTrials.gov ID
- NCT06193044
- Acronym / sponsor ID
- BE22-041
- Conditions
- Healthy Volunteer
- Keywords
- Amlodipine, Valsartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- International Bio serviceResearch network
- Study start
- 7 May 2024 (estimated)
- Primary completion
- 9 Jul 2024 (estimated)
- Study completion
- 12 Jul 2024 (estimated)
- First posted
- 5 Jan 2024 (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, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA).
Detailed description
The primary objective of this bioequivalence study is to assess and compare the rate and extent of absorption of a test formulation against a reference formulation, with an additional focus on evaluating the safety profiles of both formulations. This study aims to provide critical insights into the bioequivalence of the two formulations, shedding light on their pharmacokinetic parameters and overall safety in the context of therapeutic efficacy.
Study Design:
The study adopts an Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study design to ensure robustness and reliability in the evaluation of bioequivalence. The Replicate Crossover design minimizes the impact of inter-individual variability, allowing for a more accurate assessment of the formulations' performance.
Participant Selection:
A total of 48 healthy Thai volunteers will be recruited to participate in the study. The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements. The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison, ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation.
Study Conditions:
The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables. Fasting conditions provide a controlled environment to evaluate the formulations' performance and allow for a more accurate determination of bioequivalence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (Reference Replicate)
| Arm | Type | Receives |
|---|---|---|
| Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg | Experimental | Drug: Amlodipine/Valsartan, Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge)Participants first received Amlodipine and Valsartan Tablet USP 10/160 mg 1 tablet (Test product) in a fasting state.After a washout period of 21 days, they then recieved Exforge® 10/160 mg tablet (Reference product) in a fasting state |
| Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg | Active comparator | Drug: Amlodipine/Valsartan, Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge)Participants first received Exforge® 10/160 mg tablet 1 tablet (Reference product) in a fasting state.After a washout period of 21 days, they then recieved Amlodipine and Valsartan Tablets USP 10/160 mg (Test product) in a fasting state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-smoker and non-consumer of nicotine containing products Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
Key exclusion criteria (32 listed)
- History of allergic reaction or hypersensitivity to simvastatin or to any excipients of tablet
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/ hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of coronavirus disease starting in 2019 (COVID-19)
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period
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 |
|---|---|---|
| Amlodipine/ValsartanAlso: Amlodipine / ValsartanAmlodipine 10 mg \&valsartan 160 mg | Drug | Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg, Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg |
| Amlodipine 10 mg &valsartan 160 mg (Exforge)Also: ExforgeAmlodipine 10 mg \&valsartan 160 mg | Drug | Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg, Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg |
Primary outcome
Bioequivalence based on Cmax period
Time frame: Up to 72 hours post dose in each treatment
Bioequivalence based on Cmax period
Bioequivalence based on AUC parameters
Time frame: Up to 72 hours post dose in each treatment
Bioequivalence based on AUC parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Porranee Puranajoti, Prof. principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amlodipine/Valsartan and Amlodipine 10 mg &valsartan 160 mg (Exforge) in people with Healthy Volunteer, run by International Bio service.
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 9 inclusion and 32 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nannapat Wannaphruek, Pharm.D (024415211, nannapat.wan@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax period (time frame: Up to 72 hours post dose in each treatment). 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 9 Jan 2024.