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HealthyNCT01682577

Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

A study testing Perindopril 4 mg tablets of PT Dexa Medica and Perindopril 4 mg tablets of Servier in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier). 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?
Perindopril 4 mg tablets of PT Dexa Medica and Perindopril 4 mg tablets of Servier
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteIndonesia
Study dates
Sep 2008to Dec 2008
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
  • A body mass index in the range of 18-25 kg/m2
  • Able to participate, communicate well with the investigators and willing to give informed consent
  • Non-smokers
  • Vital signs (after 10 minutes resting) are within the following ranges:
Show all 9Show fewer
  • systolic blood pressure 100-125 mmHg
  • diastolic blood pressure 60-80 mmHg
  • pulse rate 60-90 bpm

Who cannot join

  • Pregnant or lactating women
  • Known hypersensitivity or contraindication to perindopril
  • Intake of any prescription drug within 14 days of this study's first dosing day
  • Intake of any non-prescription drug, food supplement, or herbal medicine within 7 days of this study's first dosing day
  • History or presence of any liver dysfunction (ALT, alkaline phosphatase, total bilirubin ≥ 1.5 ULN)
  • History of any bleeding or coagulation disorders
Show all 14Show fewer
  • Clinically significant ECG abnormalities
  • Clinically significant haematology abnormalities
  • Renal insufficiency (plasma creatinine concentration ≥ 1.4 mg/dL)
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
  • A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
  • A positive hepatitis B surface antigen (HBsAg), anti-HCV, and anti-HIV
  • History of drug or alcohol abuse within 12 months prior to screening of this study
  • Participation in a previous study within 3 months 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

Other trials in Indonesia

About this study

Official title: Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

Read the detailed description

The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier).

Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration.

Three weeks 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 based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).

Conditions
Healthy
Being tested
Perindopril 4 mg tablets of PT Dexa Medica, Perindopril 4 mg tablets of Servier
Keywords
Perindopril, Perindoprilat, Bioequivalence, Pharmacokinetic, Angiotensin-converting enzyme inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perindopril 4 mg tablets of PT Dexa MedicaDrug

    Also called Test Product: Perindopril 4 mg tablets of PT Dexa Medica., Each tablet contains perindopril tert-butylamine salt 4 mg

    Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

  • Perindopril 4 mg tablets of ServierDrug

    Also called Reference product: Prexum® 4 mg, produced by Servier., Each tablet contains Perindopril tert-butylamine salt 4 mg.

    Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Study groups in NCT01682577
Study groupRoleWhat they receive
Perindopril 4 mg tablets of PT Dexa MedicaExperimentalGroup I (Test product): each tablet contains perindopril tert-butylamine salt 4 mg. A single dose of perindopril tablet of PT Dexa Medica was given to each of study subjects.
Receives: Drug: Perindopril 4 mg tablets of PT Dexa Medica
Perindopril 4 mg tablets of ServierActive comparatorGroup II (Reference product) : each tablet contains perindopril tert-butylamine salt 4 mg. A single dose of perindopril (Prexum) tablets of Servier was given to each of study subjects.
Receives: Drug: Perindopril 4 mg tablets of Servier

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under concentration-time curve (AUC)of perindopril parent compound

    Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of perindopril parent compound.

    Measured: 192 hours

  2. Area under concentration-time curve (AUC)of perindoprilat

    Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of the active metabolite, perindoprilat.

    Measured: 192 hours

Secondary outcomes (6)

  1. Peak plasma concentration (Cmax)of perindopril parent compound

    Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of perindopril parent compound.

    Measured: 192 hours

  2. Peak plasma concentration (Cmax)of perindoprilat

    Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of the active metabolite, perindoprilat.

    Measured: 192 hours

  3. Time to achieve the peak plasma concentration (tmax)of perindopril parent compound

    Measured: 192 hours

  4. Time to achieve the peak plasma concentration (tmax)of perindoprilat

    Measured: 192 hours

  5. Elimination half-life (t1/2)of perindopril parent compound

    Measured: 192 hours

  6. Elimination half-life (t1/2)of perindoprilat

    Measured: 192 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2012 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2008
  4. Study completionDec 2008

Resources

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01682577
Sponsor's protocol ID
PR.122/EQL/2008
Status last verified
Sep 2012
First submitted
3 Sep 2012
Last updated
11 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • Bellissant E, Giudicelli JF. Pharmacokinetic-pharmacodynamic model for perindoprilat regional haemodynamic effects in healthy volunteers and in congestive heart failure patients. Br J Clin Pharmacol. 2001 Jul;52(1):25-33. doi: 10.1046/j.0306-5251.2001.01410.x.

    PubMed 11453887

  • Louis WJ, Workman BS, Conway EL, Worland P, Rowley K, Drummer O, McNeil JJ, Harris G, Jarrott B. Single-dose and steady-state pharmacokinetics and pharmacodynamics of perindopril in hypertensive subjects. J Cardiovasc Pharmacol. 1992 Sep;20(3):505-11. doi: 10.1097/00005344-199209000-00024.

    PubMed 1279299

  • Sennesael J, Ali A, Sweny P, Vandenburg M, Slovic D, Dratwa M, Resplandy G, Genissel P, Desche P. The pharmacokinetics of perindopril and its effects on serum angiotensin converting enzyme activity in hypertensive patients with chronic renal failure. Br J Clin Pharmacol. 1992 Jan;33(1):93-9. doi: 10.1111/j.1365-2125.1992.tb04006.x.

    PubMed 1311597

Questions about this trial

What is this clinical trial studying?

A study testing Perindopril 4 mg tablets of PT Dexa Medica and Perindopril 4 mg tablets of Servier 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 14 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 11 Sep 2012. 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 concentration-time curve (AUC)of perindopril parent compound (time frame: 192 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?

On the ClinicalTrials.gov record for NCT01682577, which also lists 3 linked publications.

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 2012.

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