HealthyPhase 1NCT01164787
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions
A Phase 1 study testing Trandolapril and Mavik in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed conditions to assess bioequivalence. To monitor adverse events and ensure safety of subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trandolapril and Mavik
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2006to May 2006
- 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
- Healthy human subjects within the age range of 18 to 45 years
- Non-smokers since at least six months
- Willingness to provide written informed consent to participate in the study
- Body-mass index of ≥ 18.5 kg/m2 and ≤24.9 kg/m2, with body weight not less than 50 kg
- Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening Normal 12-lead ECG or one with abnormality considered to be clinically insignificant Normal chest X-ray PA view Comprehension of the nature and purpose of the study and compliance with the requirement of the Protocol
- Female Subjects
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- of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (IUD), or abstinence, or
- postmenopausal for at least 1 year, or
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject
Who cannot join
- Personal/family history of allergy or hypersensitivity to Trandolapril or allied drugs
- Past history of anaphylaxis or angioedema
- Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- Presence of any clinically significCint abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
- Any cardiac, renal or liver impairment, any other organ or system impairment
- History of seizure or psychiatric disorders
Show all 19Show fewer
- Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus
- Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit).
- Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period
- Use of any recreational drug or a history of drug addiction
- Participation in any clinical trial within the past 3 months
- Inaccessibility of veins in left and right arm
- Donation of blood (one unit or 350 mL) within 3 months prior to receiVing the first dose of study medication
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and until the completion of the study.
- Receipt of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks
- An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and through out subject's participation in the study
- Consumption of grapefruit- containing food or beverages within 10 days prior to receiving the first dose of study medication in both the periods
- Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study
- Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Comparative Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited and Mavik® 4 mg Tablets of Abbott Laboratories, in Healthy, Adult, Human Subjects Under Fasting Conditions
The purpose of this study is
- To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed conditions to assess bioequivalence.
- To monitor adverse events and ensure safety of subjects.
Read the detailed description
An open label, randomised, two-treatment, two-sequence, two-period, two-way cross-over,single-dose bioequivalence study of Trandolapril4 mg Tablets manufactured by Dr. Reddy's Laboratories Ltd., Generics, India comparing with the Mavik® 4 mg Tablets (containing trandolapril 4 mg) manufactured by Abbott Laboratories, North Chicago, IL 60064, US; in healthy, adult, human subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Trandolapril, Mavik
- Keywords
- Bioequivalence, Crossover, Trandolapril
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrandolaprilDrug
Also called Mavik® 4 mg Tablets
Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited
MavikDrug
Mavik® 4 mg Tablets of Abbott Laboratories, USA.
| Study group | Role | What they receive |
|---|---|---|
| Trandolapril | Experimental | Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited Receives: Drug: Trandolapril |
| Mavik® | Active comparator | Mavik® 4 mg Tablets of Abbott Laboratories, USA. Receives: Drug: Mavik |
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMar 2006
- Primary completionApr 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Umesh Dhakate, M.B.B.S, Principal investigator, Wellquest Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164787
- Sponsor's protocol ID
- CL-028-TRAN-2006
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Comparative Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited and Mavik® 4 mg Tablets of Abbott Laboratories, in Healthy, Adult, Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01164787
- Acronym / sponsor ID
- CL-028-TRAN-2006
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Trandolapril
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Jul 2010 (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.
The purpose of this study is
- To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed conditions to assess bioequivalence.
- To monitor adverse events and ensure safety of subjects.
Detailed description
An open label, randomised, two-treatment, two-sequence, two-period, two-way cross-over,single-dose bioequivalence study of Trandolapril4 mg Tablets manufactured by Dr. Reddy's Laboratories Ltd., Generics, India comparing with the Mavik® 4 mg Tablets (containing trandolapril 4 mg) manufactured by Abbott Laboratories, North Chicago, IL 60064, US; in healthy, adult, human subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trandolapril | Experimental | Drug: TrandolaprilTrandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited |
| Mavik® | Active comparator | Drug: MavikMavik® 4 mg Tablets of Abbott Laboratories, USA. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy human subjects within the age range of 18 to 45 years
- Non-smokers since at least six months
- Willingness to provide written informed consent to participate in the study
- Body-mass index of ≥ 18.5 kg/m2 and ≤24.9 kg/m2, with body weight not less than 50 kg
- Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening Normal 12-lead ECG or one with abnormality considered to be clinically insignificant Normal chest X-ray PA view Comprehension of the nature and purpose of the study and compliance with the requirement of the Protocol
Key exclusion criteria (19 listed)
- Personal/family history of allergy or hypersensitivity to Trandolapril or allied drugs
- Past history of anaphylaxis or angioedema
- Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- Presence of any clinically significCint abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
- Any cardiac, renal or liver impairment, any other organ or system impairment
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 |
|---|---|---|
| TrandolaprilAlso: Mavik® 4 mg TabletsTrandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited | Drug | Trandolapril |
| MavikMavik® 4 mg Tablets of Abbott Laboratories, USA. | Drug | Mavik® |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 3 months
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 19 Jul 2010.
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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. Umesh Dhakate, M.B.B.S principal investigator
Wellquest Clinical Research
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 Trandolapril and Mavik in people with Healthy, run by Dr. Reddy's Laboratories Limited 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 9 inclusion and 19 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 19 Jul 2010. 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: 3 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 19 Jul 2010.