HealthyNCT01936012
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition
A study testing Lisinopril 10 mg tablets of PT Dexa Medica and Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.) 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?
- Lisinopril 10 mg tablets of PT Dexa Medica and Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- Feb 2013to Feb 2013
- 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
- Healthy male and female subjects.
- Aged 18 - 55 years inclusive.
- Non-smokers or moderate smokers (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) were within the following ranges:
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- systolic blood pressure 110 - 120 mmHg
- diastolic blood pressure 70 - 80 mmHg
- pulse rate 60 - 90 bpm
Who cannot join
- Personal/family history of allergy or hypersensitivity or contraindication to lisinopril or allied drugs.
- Pregnant or lactating women.
- Any major illness or clinically significant ongoing chronic medical illness in the past 90 days.
- Any clinically significant abnormality of liver function test (ALT, AP, total bilirubin >= 1.5 ULN).
- Any clinically significant abnormality of renal function test (serum creatinine concentration > 1.4 mg/dL).
- Positive hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
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- Clinically significant hematology abnormalities.
- Clinically significant electrocardiogram (ECG) abnormalities.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug.
- Past history of anaphylaxis or angioedema.
- History of drug or alcohol abuse within 12 months prior to screening.
- Participation in any clinical trial within the past 90 days.
- History of any bleeding or coagulative disorders.
- History of difficulty with donating blood or accessibility of veins in left or right arm.
- A donation or loss of 500 mL (or more) of blood within 3 months before the study's first dosing day.
- Intake of any prescription or non-prescription drugs, food supplements, or herbal medicines within 14 days of the 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 10 mg Lisinopril Tablets (Lisinopril 10 mg) Produced by PT Dexa Medica in Comparison With The Innovator Tablets (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, Under License From Astra Zeneca UK Ltd.)
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.)
Read the detailed description
This was a randomized, single-blind, two-period, two-sequence, cross-over study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Lisinopril 10 mg, produced by PT Dexa Medica) or one tablet of the reference drug (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.).
Blood samples were drawn immediately before taking the drug (control), and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug.
The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined from plasma concentrations of lisinopril, using liquid chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
- Conditions
- Healthy
- Being tested
- Lisinopril 10 mg tablets of PT Dexa Medica, Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
- Keywords
- Lisinopril, Bioequivalence, Bioavailability, Pharmacokinetic, Angiotensin-converting enzyme inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisinopril 10 mg tablets of PT Dexa MedicaDrug
Also called Test Product: Lisinopril 10 mg tablets of PT Dexa Medica
Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Lisinopril 10 mg tablets of PT Boehringer Ingelheim IndonesiaDrug
Also called Reference product: Zestril® 10 mg, produced by PT Boehringer Ingelheim Indonesia, under license from Astra Zeneca UK Ltd..
Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
| Study group | Role | What they receive |
|---|---|---|
| Lisinopril 10 mg tablets of PT Dexa Medica | Experimental | Each tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Dexa Medica was given to each of study subjects. Receives: Drug: Lisinopril 10 mg tablets of PT Dexa Medica |
| Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia | Active comparator | Each tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Boehringer Ingelheim Indonesia was given to each of study subjects. Receives: Drug: Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration (AUCt) of lisinopril
Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCt was determined from plasma concentration of lisinopril.
Measured: 48 hours
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of lisinopril
Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCinf was determined from plasma concentration of lisinopril.
Measured: 48 hours
Secondary outcomes (3)
The peak plasma concentration (Cmax) of lisinopril
Relative bioavailability (secondarily measured by Cmax) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. Cmax was determined from plasma concentration of lisinopril.
Measured: 48 hours
Time needed to achieve the peak plasma concentration (t max) of lisinopril
Relative bioavailability (secondarily measured by t max) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. t max was determined from plasma concentration of lisinopril.
Measured: 48 hours
The elimination half-life (t1/2) of lisinopril
Relative bioavailability (secondarily measured by t1/2) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. t1/2 was determined from plasma concentration of lisinopril.
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 posted5 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936012
- Sponsor's protocol ID
- BE.258/EQL/2012
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of 10 mg Lisinopril Tablets (Lisinopril 10 mg) Produced by PT Dexa Medica in Comparison With The Innovator Tablets (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, Under License From Astra Zeneca UK Ltd.)
- ClinicalTrials.gov ID
- NCT01936012
- Acronym / sponsor ID
- BE.258/EQL/2012
- Conditions
- Healthy
- Keywords
- Lisinopril, Bioequivalence, Bioavailability, Pharmacokinetic, Angiotensin-converting enzyme inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Sep 2013 (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 present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.)
Detailed description
This was a randomized, single-blind, two-period, two-sequence, cross-over study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Lisinopril 10 mg, produced by PT Dexa Medica) or one tablet of the reference drug (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.).
Blood samples were drawn immediately before taking the drug (control), and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug.
The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined from plasma concentrations of lisinopril, using liquid chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisinopril 10 mg tablets of PT Dexa Medica | Experimental | Drug: Lisinopril 10 mg tablets of PT Dexa MedicaEach tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Dexa Medica was given to each of study subjects. |
| Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia | Active comparator | Drug: Lisinopril 10 mg tablets of PT Boehringer Ingelheim IndonesiaEach tablet contains 10.89 mg lisinopril dihydrate that equal to 10 mg lisinopril. A single dose of lisinopril tablet of PT Boehringer Ingelheim Indonesia was given to each of study subjects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects.
- Aged 18 - 55 years inclusive.
- Non-smokers or moderate smokers (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 (16 listed)
- Personal/family history of allergy or hypersensitivity or contraindication to lisinopril or allied drugs.
- Pregnant or lactating women.
- Any major illness or clinically significant ongoing chronic medical illness in the past 90 days.
- Any clinically significant abnormality of liver function test (ALT, AP, total bilirubin >= 1.5 ULN).
- Any clinically significant abnormality of renal function test (serum creatinine concentration > 1.4 mg/dL).
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 |
|---|---|---|
| Lisinopril 10 mg tablets of PT Dexa MedicaAlso: Test Product: Lisinopril 10 mg tablets of PT Dexa MedicaEach tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. | Drug | Lisinopril 10 mg tablets of PT Dexa Medica |
| Lisinopril 10 mg tablets of PT Boehringer Ingelheim IndonesiaAlso: Reference product: Zestril® 10 mg, produced by PT Boehringer Ingelheim Indonesia, under license from Astra Zeneca UK Ltd..Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. | Drug | Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia |
Primary outcome
Area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration (AUCt) of lisinopril
Time frame: 48 hours
Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCt was determined from plasma concentration of lisinopril.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of lisinopril
Time frame: 48 hours
Relative bioavailability (primarily measured by AUCt and AUCinf) between two lisinopril 10 mg tablet formulations (test and reference formulations) was assessed under fasting condition. AUCinf was determined from plasma concentration of lisinopril.
3 secondary outcomes
The peak plasma concentration (Cmax) of lisinopril
Time frame: 48 hours
Time needed to achieve the peak plasma concentration (t max) of lisinopril
Time frame: 48 hours
The elimination half-life (t1/2) of lisinopril
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 5 Sep 2013.
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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 Lisinopril 10 mg tablets of PT Dexa Medica and Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia 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 16 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 5 Sep 2013. 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?
Area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration (AUCt) of lisinopril (time frame: 48 hours). 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 5 Sep 2013.