HealthyPhase 1NCT01164774
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions
A Phase 1 study testing Ramipril and Altace 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 characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting conditions and to assess the bioequivalence. To monitor the safety of the subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ramipril and Altace
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2005to Nov 2005
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to comply with the study procedures, in the opinion of the investigator.
- Able to give written consent for participation in the trial.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to ramipril or any other related drugs.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
- Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert
- Any history or presence of asthma (including aspirin induced asthma)or nasal polyp.
- A recent history of alcoholism < 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
- Smokers, who smoke more than 10 cigarettes/day or inability to abstain from smoking during the study.
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- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
- Note: In case, the blood loss was ≤ 200 mL, subject may be enrolled 60 days after the blood donation.
- A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti-HAV antibodies.
- A positive test result for HIV antibody and/or syphilis.
- The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of IP (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study).
- Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject can be dosed after completion of 60 days after the last sample of the previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IP and throughout the subjects' participation in the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert.
- Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-way Open Label Crossover Experimental Evaluation of Relative Bioavailabilities of Ramipril 10 mg Capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg Capsules of King Pharmaceuticals in Healthy Adult Human Male Subjects Under Non-fasting Conditions
The purpose of this study is
- To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting conditions and to assess the bioequivalence.
- To monitor the safety of the subjects.
Read the detailed description
A Two-way open label crossover experimental evaluation of relative bioavailabilities of Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King Pharmaceuticals in healthy adult human male subjects under non-fasting conditions.
- Conditions
- Healthy
- Being tested
- Ramipril, Altace
- Keywords
- Bioavailability, Crossover, Ramipril
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
Also called Altace@10 mg Capsules
Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
AltaceDrug
Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
| Study group | Role | What they receive |
|---|---|---|
| Ramipril | Experimental | Ramipril 10 mg capsules of Dr. Reddy's Laboratories Limited Receives: Drug: Ramipril |
| Altace | Active comparator | Altace@ 10 mg capsules of Kings Pharmaceuticals, USA Receives: Drug: Altace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability based on Cmax and AUC parameters
Measured: 2 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 startOct 2005
- Primary completionOct 2005
- Study completionNov 2005
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mr. Charu Gautam, MD, DNB, Principal investigator, Lambda Therapeutic Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164774
- Sponsor's protocol ID
- 075-05
- 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
- A Two-way Open Label Crossover Experimental Evaluation of Relative Bioavailabilities of Ramipril 10 mg Capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg Capsules of King Pharmaceuticals in Healthy Adult Human Male Subjects Under Non-fasting Conditions
- ClinicalTrials.gov ID
- NCT01164774
- Acronym / sponsor ID
- 075-05
- Conditions
- Healthy
- Keywords
- Bioavailability, Crossover, Ramipril
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Nov 2005 (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 characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting conditions and to assess the bioequivalence.
- To monitor the safety of the subjects.
Detailed description
A Two-way open label crossover experimental evaluation of relative bioavailabilities of Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King Pharmaceuticals in healthy adult human male subjects under non-fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramipril | Experimental | Drug: RamiprilRamipril 10 mg capsules of Dr. Reddy's Laboratories Limited |
| Altace | Active comparator | Drug: AltaceAltace@ 10 mg capsules of Kings Pharmaceuticals, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to comply with the study procedures, in the opinion of the investigator.
- Able to give written consent for participation in the trial.
Key exclusion criteria (18 listed)
- Known hypersensitivity or idiosyncratic reaction to ramipril or any other related drugs.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
- Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert
- Any history or presence of asthma (including aspirin induced asthma)or nasal polyp.
- A recent history of alcoholism < 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
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 |
|---|---|---|
| RamiprilAlso: Altace@10 mg CapsulesRamipril 10 mg Capsules of Dr. Reddy's Laboratories Limited | Drug | Ramipril |
| AltaceAltace@ 10 mg capsules of Kings Pharmaceuticals, USA | Drug | Altace |
Primary outcome
Bioavailability based on Cmax and AUC parameters
Time frame: 2 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.
Mr. Charu Gautam, MD, DNB principal investigator
Lambda Therapeutic Research Limited
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 Ramipril and Altace 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 5 inclusion and 18 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?
Bioavailability based on Cmax and AUC parameters (time frame: 2 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.