FastingPhase 1NCT01713647
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
A Phase 1 study testing Amlodipin, losartan, HCTZ in people with Fasting, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Amlodipin, losartan, HCTZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2012to Dec 2012
- Phase
- Phase 1
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- Any significant clinical abnormality including HBsAg, HCV, and HIV
- Abnormal vital signs.
- Abnormal Kidney or Liver function tests.
- Vomiting, Diarrhea.
- Pre dosing blood pressure less than 110/70 mmHg
- Positive test for elicit drugs and alcohol prior to dosing in each period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized,, Single Dose, Open-label, Crossover Bioequivalence Study of LOSANET AM PLUS 10mg/100mg/12.5 mg Tablets (One Tablet) of (PHARMALINE, Lebanon) Versus NORVASC 10mg Tablets (One Tablet) of (Pfizer Canada Inc., Kirkland (Quebec)) and HYZAAR 100mg/12.5 Tablets (One Tablet) of (Merck Sharp & Dohme, Quimica de Puerto Rico, Inc, Road 2 Km. 60.3, Sabana Hoyos, Arecibo, PR 00688 for Merck Sharp & Dohme B.V. Haarlem, The Netherlands) in Healthy Subjects Under Fasting Conditions.
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
- Being tested
- Amlodipin, losartan, HCTZ
- Keywords
- Bio-equivalence, crossover
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipin, losartan, HCTZDrug
Also called LOSANET AM PLUS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Amlodipin, losartan, HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Research Unit, Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rana .T Bustami, Phd.pharmacy, Principal investigator, PRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713647
- Sponsor's protocol ID
- AMLH423/PRO-00
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized,, Single Dose, Open-label, Crossover Bioequivalence Study of LOSANET AM PLUS 10mg/100mg/12.5 mg Tablets (One Tablet) of (PHARMALINE, Lebanon) Versus NORVASC 10mg Tablets (One Tablet) of (Pfizer Canada Inc., Kirkland (Quebec)) and HYZAAR 100mg/12.5 Tablets (One Tablet) of (Merck Sharp & Dohme, Quimica de Puerto Rico, Inc, Road 2 Km. 60.3, Sabana Hoyos, Arecibo, PR 00688 for Merck Sharp & Dohme B.V. Haarlem, The Netherlands) in Healthy Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01713647
- Acronym / sponsor ID
- AMLH423/PRO-00
- Conditions
- Fasting
- Keywords
- Bio-equivalence, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pharmaceutical Research Unit, JordanUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOSANET AM PLUS (10/100/12.5 mg) of PHARMALINE, Lebanon | Experimental | Drug: Amlodipin, losartan, HCTZSubjects 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 |
| NORVASC & HYZAAR (100/12.5 mg) | Active comparator | Drug: Amlodipin, losartan, HCTZSubjects 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipin, losartan, HCTZAlso: LOSANET AM PLUS | Drug | LOSANET AM PLUS (10/100/12.5 mg) of PHARMALINE, Lebanon, NORVASC & HYZAAR (100/12.5 mg) |
Primary outcome
To assess the bioequivalence of Test oral formulation of LOSANET AM PLUS versus References NORVASC and HYZAAR.
Time frame: 9 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana .T Bustami, Phd.pharmacy principal investigator
PRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amlodipin, losartan, HCTZ in people with Fasting, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.
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 11 inclusion and 24 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 25 Jul 2013. 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 Jordan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the bioequivalence of Test oral formulation of LOSANET AM PLUS versus References NORVASC and HYZAAR. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2013.