HealthyPhase 1NCT00863915
A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce
A Phase 1 study testing Ramipril10 mg Capsules, single dose and Atlace® 10 mg capsules, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product Atlace® manufactured by Monarch Pharmaceuticals Inc. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ramipril10 mg Capsules, single dose and Atlace® 10 mg capsules, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2004
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be a male or non-pregnant, non-breast-feeding female.
- Subject must be between 18 and 55 years of age inclusive.
- Subject's body weight should be within ±15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table.
- Female subjects of childbearing potential --- not surgically sterile or at least two years postmenopausal-- must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
- Subject is willing and able to remain in the research center for the entire duration of each confinement period and return to the research center for any outpatient visits.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
- History or presence of allergic or adverse response to the study drug or related drugs.
- Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
- Has donated blood or plasma within 30 days prior to the first dose of study medication.
- Has participated in another clinical trial within 30 days prior to first dose of study medication.
Show all 14Show fewer
- Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication.
- Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication.
- Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
- Has a history of substance abuse (including alcohol) in the past 5 years
- Is female with a positive pregnancy test.
- Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
- Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce
To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product Atlace® manufactured by Monarch Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to healthy subjects after a 10-hour overnight fast
Read the detailed description
Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Ramipril10 mg Capsules, single dose, Atlace® 10 mg capsules, single dose
- Keywords
- Bioequivalence, Ramipril, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril10 mg Capsules, single doseDrug
Also called Ramipril
A: Experimental Subjects received Purepac formulated products sprinkled on one tablespoonful of applesauce
Atlace® 10 mg capsules, single doseDrug
Also called Ramipril
B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products sprinkled on one tablespoonful of applesauce
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ramipril10 mg Capsules, single dose Receives: Drug: Ramipril10 mg Capsules, single dose |
| B | Active comparator | Atlace® 10 mg capsules, single dose Receives: Drug: Atlace® 10 mg capsules, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2004
- Primary completionOct 2004
- Study completionOct 2004
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel V. Freeland,, D.O., CCI, Principal investigator, CEDRA Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863915
- Sponsor's protocol ID
- 20-679-1G
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce
- ClinicalTrials.gov ID
- NCT00863915
- Acronym / sponsor ID
- 20-679-1G
- Conditions
- Healthy
- Keywords
- Bioequivalence, Ramipril, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 18 Mar 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.
To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product Atlace® manufactured by Monarch Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to healthy subjects after a 10-hour overnight fast
Detailed description
Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ramipril10 mg Capsules, single doseRamipril10 mg Capsules, single dose |
| B | Active comparator | Drug: Atlace® 10 mg capsules, single doseAtlace® 10 mg capsules, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must be a male or non-pregnant, non-breast-feeding female.
- Subject must be between 18 and 55 years of age inclusive.
- Subject's body weight should be within ±15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table.
- Female subjects of childbearing potential --- not surgically sterile or at least two years postmenopausal-- must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
Key exclusion criteria (14 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
- History or presence of allergic or adverse response to the study drug or related drugs.
- Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
- Has donated blood or plasma within 30 days prior to the first dose of study medication.
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 |
|---|---|---|
| Ramipril10 mg Capsules, single doseAlso: RamiprilA: Experimental Subjects received Purepac formulated products sprinkled on one tablespoonful of applesauce | Drug | A |
| Atlace® 10 mg capsules, single doseAlso: RamiprilB: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products sprinkled on one tablespoonful of applesauce | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 96 hours
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 16 Aug 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Daniel V. Freeland,, D.O., CCI principal investigator
CEDRA Clinical Research, LLC
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 Ramipril10 mg Capsules, single dose and Atlace® 10 mg capsules, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
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 6 inclusion and 14 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 16 Aug 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 United States. 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?
Rate and Extend of Absorption (time frame: 96 hours). 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 16 Aug 2010.