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Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions

NCT01713647 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2013-07-25

No results posted yet for this study

Summary

To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid losartan metabolite \& Hydrochlorothiazide in plasma and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.

Conditions

  • Fasting

Interventions

DRUG

Amlodipin, losartan, HCTZ

Sponsors & Collaborators

  • Pharmaceutical Research Unit, Jordan

    lead OTHER

Principal Investigators

  • Rana .T Bustami, Phd.pharmacy · PRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713647 on ClinicalTrials.gov