FastingPhase 1NCT01831700
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
A Phase 1 study testing Lisinopril and Hydrochlorothiazide Tablets (20+25) mg and Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg and Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2012to Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
- Subject willing to give written informed consent.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry including serum electrolytes test, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if taken).
- Willingness to follow the protocol requirements as evidenced by written informed consent.
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- Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study \& during the course of the study.
- No history of drug abuse in the past one year.
- Non-smokers and Non-alcoholics.
- For female subject:
- Was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm , Intrauterine device and Abstinence. OR
- Was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
Who cannot join
- Known history of hypersensitivity to Lisinopril and Hydrochlorothiazide, other sulfonamide-derived drugs or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
- Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
- History of malignancy or other serious diseases.
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- Refusal to abstain from food from at least ten (10.00) hours prior to study drug administration until at least four (04.00) hours post-dose, in each study period.
- Any contraindication to blood sampling or difficulty in accessibility of veins.
- Refusal to abstain from fluid from at least 01.00 hour prior to study drug administration until at least 01.00 hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
- Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
- Blood donation within 90 days prior to the commencement of the study.
- Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
- Found positive in breath alcohol test done before check-in for each study period.
- Found positive in urine test for drug abuse done before check-in for each study period.
- Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.
- History of problem in swallowing tablet(s).
- Female subject, demonstrating positive urine pregnancy test at the time of screening.
- Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
- Female subject, currently breast feeding or lactating.
- Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India With Zestoretic® 20/25 Lisinopril/Hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of clinical phase was 12 days, including the washout period of 7 days between each study period.
- Conditions
- Fasting
- Being tested
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisinopril and Hydrochlorothiazide Tablets (20+25) mgDrug
Also called Test product
Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
Zestoretic® 20/25 lisinopril/hydrochlorothiazide TabletsDrug
Also called Reference product
Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
| Study group | Role | What they receive |
|---|---|---|
| Lisinopril and Hydrochlorothiazide Tablets (20+25) mg | Experimental | Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India Receives: Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg; Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets |
| Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets | Active comparator | Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA Receives: Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg; Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence is based on Cmax and AUC parameters.
Sampling Hours: Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
Measured: 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Tarang Girishbhai Shah, M. D. (Pharmacology), Principal investigator, Accutest Research Lab (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831700
- Sponsor's protocol ID
- Ipca/ARL/10/386
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India With Zestoretic® 20/25 Lisinopril/Hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT01831700
- Acronym / sponsor ID
- Ipca/ARL/10/386
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Apr 2013 (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.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of clinical phase was 12 days, including the washout period of 7 days between each study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisinopril and Hydrochlorothiazide Tablets (20+25) mg | Experimental | Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide TabletsLisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India |
| Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets | Active comparator | Drug: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Drug: Zestoretic® 20/25 lisinopril/hydrochlorothiazide TabletsZestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male and non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
- Subject willing to give written informed consent.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry including serum electrolytes test, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if taken).
Key exclusion criteria (20 listed)
- Known history of hypersensitivity to Lisinopril and Hydrochlorothiazide, other sulfonamide-derived drugs or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
- Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
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 |
|---|---|---|
| Lisinopril and Hydrochlorothiazide Tablets (20+25) mgAlso: Test productLisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day | Drug | Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets |
| Zestoretic® 20/25 lisinopril/hydrochlorothiazide TabletsAlso: Reference productZestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day | Drug | Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 1 Months
Sampling Hours: Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
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 15 Apr 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.
Dr. Tarang Girishbhai Shah, M. D. (Pharmacology) principal investigator
Accutest Research Lab (I) Pvt. Ltd.
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 Lisinopril and Hydrochlorothiazide Tablets (20+25) mg and Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
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 12 inclusion and 20 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 15 Apr 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 India. 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?
Bioequivalence is based on Cmax and AUC parameters. (time frame: 1 Months). 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 15 Apr 2013.