NCT01682577

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

September 3, 2012

Last Update Submit

September 6, 2012

Conditions

Healthy

Keywords

PerindoprilPerindoprilatBioequivalencePharmacokineticAngiotensin-converting enzyme inhibitor

Outcome Measures

Primary Outcomes (2)

  • 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.

    192 hours

  • 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.

    192 hours

Secondary Outcomes (6)

  • Peak plasma concentration (Cmax)of perindopril parent compound

    192 hours

  • Peak plasma concentration (Cmax)of perindoprilat

    192 hours

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

    192 hours

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

    192 hours

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

    192 hours

  • +1 more secondary outcomes

Study Arms (2)

Perindopril 4 mg tablets of PT Dexa Medica

EXPERIMENTAL

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

Perindopril 4 mg tablets of Servier

ACTIVE COMPARATOR

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

Perindopril 4 mg tablets of PT Dexa MedicaDRUG

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
Perindopril 4 mg tablets of PT Dexa Medica
Perindopril 4 mg tablets of ServierDRUG

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.
Perindopril 4 mg tablets of Servier

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

Related Publications (3)

  • 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.

    PMID: 11453887BACKGROUND

  • 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.

    PMID: 1279299BACKGROUND

  • 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.

    PMID: 1311597BACKGROUND

MeSH Terms

Interventions

Perindopril

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Danang A Yunaidi, MD

    PT Equilab International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 11, 2012

Study Start

September 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

ID(1)