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

NCT01713647 | Completed Phase 1

• 1 other identifier: AMLH423/PRO-00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bio-equivalence, crossover

Outcome Measures

Primary Outcomes (1)

• To assess the bioequivalence of Test oral formulation of LOSANET AM PLUS versus References NORVASC and HYZAAR.

  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. Cmax Ratio: Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the variance of σw2 within subject variability for the reference based on Amlodipine, Losartan, \& Hydrochlorothiazide AUC Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Losartan, \& Hydrochlorothiazide AUC0-72 Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00 - 125.00 % based on Amlodipine Carboxylic acid Losartan metabolite will be considered as supportive data

  9 weeks

Study Arms (2)

LOSANET AM PLUS (10/100/12.5 mg) of PHARMALINE, Lebanon

EXPERIMENTAL

Subjects will be fasted overnight and receive one tablet by mouth in accordance with randomization table, and blood samples will be taken at specified intervals over 3 days intervention: Drug: LOSANET AM PLUS Amlodipine/ Losartan/Hydrochlorothiazide Other Name: NA

Drug: Amlodipin, losartan, HCTZ

NORVASC & HYZAAR (100/12.5 mg)

ACTIVE COMPARATOR

Subjects will be fasted overnight and receive one tablet of Norvasc \&HYZAAR by mouth in accordance with randomization table, and blood samples will be taken over 3 days intervention: Drug: LOSANET AM PLUS Amlodipine/ Losartan/Hydrochlorothiazide Other Name: NA

Drug: Amlodipin, losartan, HCTZ

Interventions

Amlodipin, losartan, HCTZ DRUG

Also known as: LOSANET AM PLUS

LOSANET AM PLUS (10/100/12.5 mg) of PHARMALINE, Lebanon; NORVASC & HYZAAR (100/12.5 mg)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects.
• Ethnic Group: Arab \& Mediterranean
• Race: Mixed skin (white \& black skin people).
• Age 18-50 years
• Body-mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight).
• Subject is available for the whole study period and gave written informed consent
• Physical examination within normal ranges
• All laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician
• Vital signs within normal ranges.
• Kidney function test, Liver function test should be within normal ranges.
• Pre dosing blood pressure more than 110/70 mmHg.

You may not qualify if:

• Women of childbearing potential, pregnant and lactating women.
• Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
• History of severe allergy or allergic reactions to study drug or related drugs or heparin
• Known history or presence of food allergies, or any surgical or medical condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
• History of serious illness that can impact fate of drugs
• Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate
• Clinically significant illness 4 weeks before study Period I
• Serious mental disease, drug, alcohol, solvents or caffeine abuse, smoking.
• Regular use of medication
• Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) during one month before the study initiation
• Presence of any significant physical or organ abnormality
• Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
• Participation in another bioequivalence study within 80 days prior to the start of this study Period I
• Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
• Prior history of hypersensitivity to Amlodipine besylate, Losartan Potassium \& Hydrochlorothiazide.

Sponsors & Collaborators

• Pharmaceutical Research Unit, Jordan: lead

Study Sites (1)

Pharmaceutical research unit

Amman, Amman Governorate, 1084, Jordan

Location

MeSH Terms

Conditions

Fasting

Interventions

Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rana .T Bustami, Phd.pharmacy

  PRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 25, 2013

Record last verified: 2012-10

Locations

JO (1)