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CompletedNCT01682577Updated Sep 11, 2012

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

An interventional study of Perindopril 4 mg tablets of PT Dexa Medica and Perindopril 4 mg tablets of Servier in Healthy, sponsored by Dexa Medica Group. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-11.

Sponsored by Dexa Medica Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Healthy

Keywords

  • Perindopril
  • Perindoprilat
  • Bioequivalence
  • Pharmacokinetic
  • Angiotensin-converting enzyme inhibitor
03

In context

Lead sponsor

Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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:

    • systolic blood pressure 100-125 mmHg
    • diastolic blood pressure 60-80 mmHg
    • pulse rate 60-90 bpm

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Perindopril 4 mg tablets of PT Dexa Medica

    Group 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.

    Drug: Perindopril 4 mg tablets of PT Dexa Medica

  • Active comparator
    Perindopril 4 mg tablets of Servier

    Group 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.

    Drug: Perindopril 4 mg tablets of Servier

Interventions

  • DrugPerindopril 4 mg tablets of PT Dexa Medica

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

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

  • DrugPerindopril 4 mg tablets of Servier

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

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 192 hours

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 192 hours

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

    Time frame: 192 hours

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

    Time frame: 192 hours

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

    Time frame: 192 hours

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

    Time frame: 192 hours

07

Study locations

1 site
  • PT Equilab International
    Jakarta, 12430, Indonesia
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01682577
Lead sponsor
Dexa Medica Group
Responsible party
Sponsor
First posted
Sep 11, 2012
Start date
Sep 2008
Primary completion
Nov 2008
Completion
Dec 2008
Last update
Sep 11, 2012

Study contacts

Danang A Yunaidi, MD
principal investigator · PT Equilab International

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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