HealthyNCT02518451
Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
A study testing Valsartan 160 mg film-coated caplets (test formulation) and Valsartan 160 mg film-coated caplets (reference formulation) in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valsartan 160 mg film-coated caplets (test formulation) and Valsartan 160 mg film-coated caplets (reference formulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
- Aged 18 - 55 years inclusive
- Preferably non-smokers or smoke less than 10 cigarettes per day.
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Body mass index within 18 to 25 kg/m2.
- Vital signs (after 10 minutes rest) must be within the following ranges:
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- Systolic blood pressure : 110 - 120 mm Hg
- Diastolic blood pressure : 70 - 80 mm Hg
- Pulse rate : 60 - 90 bpm
Who cannot join
- Personal/family history of allergy or hypersensitivity or contraindication to valsartan or allied drugs.
- Pregnant or lactating women (urinary pregnancy test will be applied to women subjects just before taking the study drug).
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, hypotensive episodes, hyperglycemia, etc.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL), etc.
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
- Clinically significant haematology abnormalities.
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- Clinically significant electrocardiogram (ECG) abnormalities.
- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery.
- Past history of anaphylaxis or angioedema.
- History of drug or alcohol abuse within 12 months prior to screening for this study.
- Participation in any clinical trial within the past 90 days calculated from the last visit.
- History of any bleeding or coagulative disorders.
- History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
- A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day.
- Intake of any prescription or non-prescription drug, food supplement or herbal medicine within 14 days of this study's first dosing day.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
PT Equilab International
Jakarta, Jakarta Special Capital Region, 12430
About this study
Official title: Bioequivalence Study of 160 mg Valsartan Film-coated Caplets Produced by PT Dexa Medica in Comparison With the Innovator Film-coated Tablets (Diovan® 160, Novartis Pharma AG)
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.
Read the detailed description
In the first period, subjects received either the test formulation (160 mg valsartan film-coated caplets produced by PT Dexa Medica, Palembang, Indonesia) once daily, or the innovator film-coated tablets (Diovan® 160, Novartis Farmaceutica S.A., Barbera del Valles, Spain for Novartis Pharma AG, Basel, Switzerland) once daily as the reference formulation. In the subsequent period, after a one-week wash-out period, they received the alternate drug.
At the night before starting the study, subjects were instructed to fast from any food and drink but mineral water for 9 hours before the drug administration. In the morning after, at the dosing day, each of the 48 subjects then swallowed (without chewing) one dose of valsartan 160 mg of the test formulation or of the reference formulation, with 200 mL of water. As much as 5 mL of blood samples for drug assay were drawn again from each subject, at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16, 24, 36, and 48 hours after dosing.
The concentrations of valsartan in plasma were assayed using a validated high performance liquid chromatography with fluorescence detector (HPLC-FL) method. Pharmacokinetic parameters, including the area under the concentration-versus-time curve (AUC) from time zero to the time of last quatifiable concentration (48 hours after dosing) (AUC-t), AUC from time zero extrapolated to infinity (AUC-inf), maximum concentration (Cmax), time to reach the maximum concentration (tmax), and half-life (t1/2), were assessed in this study.
- Conditions
- Healthy
- Being tested
- Valsartan 160 mg film-coated caplets (test formulation), Valsartan 160 mg film-coated caplets (reference formulation)
- Keywords
- antihypertensive, bioequivalence, formulation, pharmakokinetic, valsartan, subjects, Fasting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 160 mg film-coated caplets (test formulation)Drug
Also called Valsartan 160 mg of PT Dexa Medica
In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
Valsartan 160 mg film-coated caplets (reference formulation)Drug
Also called Diovan® 160
In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
| Study group | Role | What they receive |
|---|---|---|
| (Test) Group I | Experimental | Valsartan 160 mg film-coated caplets of PT Dexa Medica Receives: Drug: Valsartan 160 mg film-coated caplets (test formulation) |
| (Reference) Group II | Active comparator | Valsartan 160 mg film-coated caplets (Diovan® 160) Receives: Drug: Valsartan 160 mg film-coated caplets (reference formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the curve of plasma concentrations versus time from time zero to the time of last observed quantifiable concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Measured: 48 hours
AUCinf
Area under the curve of plasma concentrations versus time from time zero to infinity was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Measured: 48 hours
Cmax
The maximum (peak) plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Measured: 48 hours
Secondary outcomes (2)
Tmax
The time of peak plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Measured: 48 hours
T1/2
The elimination half-life was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionMar 2014
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Effi Setiawati, MSc, Study director, PT Equilab International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518451
- Sponsor's protocol ID
- PR. 183/EQL/2010
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of 160 mg Valsartan Film-coated Caplets Produced by PT Dexa Medica in Comparison With the Innovator Film-coated Tablets (Diovan® 160, Novartis Pharma AG)
- ClinicalTrials.gov ID
- NCT02518451
- Acronym / sponsor ID
- PR. 183/EQL/2010
- Conditions
- Healthy
- Keywords
- antihypertensive, bioequivalence, formulation, pharmakokinetic, valsartan, subjects, Fasting conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.
Detailed description
In the first period, subjects received either the test formulation (160 mg valsartan film-coated caplets produced by PT Dexa Medica, Palembang, Indonesia) once daily, or the innovator film-coated tablets (Diovan® 160, Novartis Farmaceutica S.A., Barbera del Valles, Spain for Novartis Pharma AG, Basel, Switzerland) once daily as the reference formulation. In the subsequent period, after a one-week wash-out period, they received the alternate drug.
At the night before starting the study, subjects were instructed to fast from any food and drink but mineral water for 9 hours before the drug administration. In the morning after, at the dosing day, each of the 48 subjects then swallowed (without chewing) one dose of valsartan 160 mg of the test formulation or of the reference formulation, with 200 mL of water. As much as 5 mL of blood samples for drug assay were drawn again from each subject, at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16, 24, 36, and 48 hours after dosing.
The concentrations of valsartan in plasma were assayed using a validated high performance liquid chromatography with fluorescence detector (HPLC-FL) method. Pharmacokinetic parameters, including the area under the concentration-versus-time curve (AUC) from time zero to the time of last quatifiable concentration (48 hours after dosing) (AUC-t), AUC from time zero extrapolated to infinity (AUC-inf), maximum concentration (Cmax), time to reach the maximum concentration (tmax), and half-life (t1/2), were assessed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Test) Group I | Experimental | Drug: Valsartan 160 mg film-coated caplets (test formulation)Valsartan 160 mg film-coated caplets of PT Dexa Medica |
| (Reference) Group II | Active comparator | Drug: Valsartan 160 mg film-coated caplets (reference formulation)Valsartan 160 mg film-coated caplets (Diovan® 160) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
- Aged 18 - 55 years inclusive
- Preferably non-smokers or smoke less than 10 cigarettes per day.
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Body mass index within 18 to 25 kg/m2.
Key exclusion criteria (15 listed)
- Personal/family history of allergy or hypersensitivity or contraindication to valsartan or allied drugs.
- Pregnant or lactating women (urinary pregnancy test will be applied to women subjects just before taking the study drug).
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, hypotensive episodes, hyperglycemia, etc.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL), etc.
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
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 160 mg film-coated caplets (test formulation)Also: Valsartan 160 mg of PT Dexa MedicaIn each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered. | Drug | (Test) Group I |
| Valsartan 160 mg film-coated caplets (reference formulation)Also: Diovan® 160In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered. | Drug | (Reference) Group II |
Primary outcome
AUCt
Time frame: 48 hours
Area under the curve of plasma concentrations versus time from time zero to the time of last observed quantifiable concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
AUCinf
Time frame: 48 hours
Area under the curve of plasma concentrations versus time from time zero to infinity was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
Cmax
Time frame: 48 hours
The maximum (peak) plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)
2 secondary outcomes
Tmax
Time frame: 48 hours
T1/2
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Effi Setiawati, MSc study director
PT Equilab International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsartan 160 mg film-coated caplets (test formulation) and Valsartan 160 mg film-coated caplets (reference formulation) in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
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 15 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: finished, as of the sponsor's last update on 7 Aug 2015. 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 Indonesia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUCt (time frame: 48 hours). The study lists 3 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 7 Aug 2015.