HealthyNCT02197494
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
A study testing Valsartan in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2014to 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, human volunteers between 18 to 45 years of age (both inclusive) living in and around Mumbai city or western part of India.
- Having a Body Mass Index (BMI) between 18.5 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
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- Surgically sterilized at least 6 months prior to study participation; Or
- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- And
- Pregnancy test must be negative.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to valsartan or any of the formulation excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats per minute at the time of screening.
- Presence of orthostatic hypotension.
- If the QTc interval were to be more than 450 ms on ECG measurement at the time of screening.
- Ingestion of a medicine (including herbal remedies) at any time within 14 days before dosing in period-I. In any such case subject selection were at the discretion of the Principal Investigator.
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- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 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) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
- Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- History or presence of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine in period-I. In any such case subject selection were at the discretion of the Principal Investigator.
- Consumption of grapefruit or grapefruit products within 48 hours prior to dosing.
- Nursing mothers (females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two Period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Two Formulations of Valsartan 320mg Tablet in Healthy, Adult, Human Subjects Under Fed Condition.
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.
Read the detailed description
After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes.
A single oral dose (320 mg) of either the test or the reference product was administered to the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of drinking water at ambient temperature. The IMP administration was as per the randomization schedule and under open-label condition.
A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02 mL, were collected from each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic profile of the test as well as the reference drug.
The pharmacokinetic parameters were calculated from the drug concentration vs. time profile by non-compartmental model using WinNonlin Professional Software Version 5.3 (Pharsight Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute Inc., USA) to assess the bioequivalence of both the formulations.
- Conditions
- Healthy
- Being tested
- Valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
320mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Valsartan Tablets USP 320 mg DIVIS Receives: Drug: Valsartan |
| Reference | Active comparator | Diovan® (Valsartan) 320 Tablets Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan
Measured: 0-36 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197494
- Sponsor's protocol ID
- 042-14
- Status last verified
- Jul 2014
- First submitted
- 21 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two Period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Two Formulations of Valsartan 320mg Tablet in Healthy, Adult, Human Subjects Under Fed Condition.
- ClinicalTrials.gov ID
- NCT02197494
- Acronym / sponsor ID
- 042-14
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Jul 2014 (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.
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.
Detailed description
After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes.
A single oral dose (320 mg) of either the test or the reference product was administered to the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of drinking water at ambient temperature. The IMP administration was as per the randomization schedule and under open-label condition.
A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02 mL, were collected from each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic profile of the test as well as the reference drug.
The pharmacokinetic parameters were calculated from the drug concentration vs. time profile by non-compartmental model using WinNonlin Professional Software Version 5.3 (Pharsight Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute Inc., USA) to assess the bioequivalence of both the formulations.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: ValsartanValsartan Tablets USP 320 mg DIVIS |
| Reference | Active comparator | Drug: ValsartanDiovan® (Valsartan) 320 Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy, adult, human volunteers between 18 to 45 years of age (both inclusive) living in and around Mumbai city or western part of India.
- Having a Body Mass Index (BMI) between 18.5 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
Key exclusion criteria (20 listed)
- Known hypersensitivity or idiosyncratic reaction to valsartan or any of the formulation excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats per minute at the time of screening.
- Presence of orthostatic hypotension.
- If the QTc interval were to be more than 450 ms on ECG measurement at the time of screening.
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 |
|---|---|---|
| Valsartan320mg tablets | Drug | Reference, Test |
Primary outcome
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan
Time frame: 0-36 hrs
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 22 Jul 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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 study testing Valsartan in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
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 10 inclusion and 20 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 22 Jul 2014. 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 India. 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?
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan (time frame: 0-36 hrs). 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 22 Jul 2014.