HealthyNCT00879788
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
A study testing Ramipril 10mg capsules in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured by King Pharmaceuticals Inc, Bristol and… 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 10mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2006to Mar 2007
- Phase
- Interventional
- 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
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- Had a non-vegetarian diet habit.
Who cannot join
- Hypersensitivity, allergy to ramipril or related group of drugs.
- History of anaphylaxis/anaphylactoid reactions.
- History of fever in the week preceding the study.
- History of seizures and sleep disorders.
- History of chronic cough, bronchial asthma.
- Subject who had sitting systolic blood pressure of less than 90 mmHg or >140 mmHg and diastolic blood pressure of less than 60 mmHg or > 90 mmHg at predose.
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- History of frequent syncopal attacks, frequent palpitations.
- History of angina, myocardial infarction or angioedema.
- History of severe diarrhea or vomiting in the week preceding the study.
- History of dry cough.
- History of congestive heart failure.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- History of any psychiatric illness, which might impair the ability to provide written informed consent.
- Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.
Trial locations and contacts
1 site in 1 country.
India1 site
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, 110 062
About this study
Official title: An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study Comparing Ramipril 10 mg Capsules of Ohm Laboratories Inc. (A Subsidiary of Ranbaxy Pharmaceuticals Inc.), With Altace® Capsule 10 mg (Containing Ramipril 10 mg) of Monarch Pharmaceuticals Inc, USA in Healthy, Adult, Male, Human Subjects Under Fed Conditions.
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol in healthy, adult, male, human subjects under fed condition.
Read the detailed description
A single oral dose of ramipril 10 mg capsule was administered with 240 mL of drinking water at ambient temperature 30 minutes after start of a high-fat high-caloric breakfast under the supervision of trained study personnel.
A total of thirty-two (32) subjects were randomized to receive a single oral dose of the test (T) and reference (R) formulation of ramipril 10 mg capsule. One subject (subject No. 18) was withdrawn and one dropped out (subject No. 10) from the study in period I. One subject (subject No. 20) dropped out and two subjects were withdrawn (subject No. 27, 29) from the study in period II.
A total of twenty-seven (27) subjects completed both the periods of the study.
- Conditions
- Healthy
- Being tested
- Ramipril 10mg capsules
- Keywords
- Ramipril fed condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril 10mg capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ramipril capsules 10 mg (containing Ramipril 10 mg)of of OHM Laboratories Inc., USA (a subsidiary of Ranbaxy Pharmaceuticals Inc), USA Receives: Drug: Ramipril 10mg capsules |
| 2 | Active comparator | ALTACE® capsule 10 mg (containing Ramipril 10 mg)of King Pharmaceuticals Inc., Bristol, TN 37620, USA Receives: Drug: Ramipril 10mg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fed conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionNov 2006
- Study completionMar 2007
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879788
- Sponsor's protocol ID
- 135_RAMIP_06
- Status last verified
- Apr 2009
- First submitted
- 9 Apr 2009
- Last updated
- 10 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study Comparing Ramipril 10 mg Capsules of Ohm Laboratories Inc. (A Subsidiary of Ranbaxy Pharmaceuticals Inc.), With Altace® Capsule 10 mg (Containing Ramipril 10 mg) of Monarch Pharmaceuticals Inc, USA in Healthy, Adult, Male, Human Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT00879788
- Acronym / sponsor ID
- 135_RAMIP_06
- Conditions
- Healthy
- Keywords
- Ramipril fed condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Apr 2009 (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 study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol in healthy, adult, male, human subjects under fed condition.
Detailed description
A single oral dose of ramipril 10 mg capsule was administered with 240 mL of drinking water at ambient temperature 30 minutes after start of a high-fat high-caloric breakfast under the supervision of trained study personnel.
A total of thirty-two (32) subjects were randomized to receive a single oral dose of the test (T) and reference (R) formulation of ramipril 10 mg capsule. One subject (subject No. 18) was withdrawn and one dropped out (subject No. 10) from the study in period I. One subject (subject No. 20) dropped out and two subjects were withdrawn (subject No. 27, 29) from the study in period II.
A total of twenty-seven (27) subjects completed both the periods of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ramipril 10mg capsulesRamipril capsules 10 mg (containing Ramipril 10 mg)of of OHM Laboratories Inc., USA (a subsidiary of Ranbaxy Pharmaceuticals Inc), USA |
| 2 | Active comparator | Drug: Ramipril 10mg capsulesALTACE® capsule 10 mg (containing Ramipril 10 mg)of King Pharmaceuticals Inc., Bristol, TN 37620, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- Had a non-vegetarian diet habit.
Key exclusion criteria (25 listed)
- Hypersensitivity, allergy to ramipril or related group of drugs.
- History of anaphylaxis/anaphylactoid reactions.
- History of fever in the week preceding the study.
- History of seizures and sleep disorders.
- History of chronic cough, bronchial asthma.
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 |
|---|---|---|
| Ramipril 10mg capsules | Drug | 1, 2 |
Primary outcome
Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fed conditions
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 10 Apr 2009.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramipril 10mg capsules in people with Healthy, run by Ranbaxy 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 25 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 10 Apr 2009. 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.
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 evaluation of Ranbaxy Ramipril 10mg Capsules under fed conditions. 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 10 Apr 2009.