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A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fed Conditions
NCT00864162 · View on ClinicalTrials.gov ↗
Study 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. administrated to healthy subjects after a 10-hour overnight fast followed by a high-calorie, high-fat breakfast meal.
Conditions Studied
Interventions
- DRUG Ramipril10 mg Capsules, single dose
- DRUG Atlace® 10 mg capsules, single dose
Study Locations (1)
Texas
- CEDRA Clinical Research, LLC — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-09 |
| Est. Completion | 2004-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864162
The ClinicalTrials.gov registry entry for NCT00864162 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Ramipril10 mg Capsules, single dose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00864162 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00864162 about?
NCT00864162 is a clinical study titled "A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fed Conditions". 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 to h...
What is the current status of trial NCT00864162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-09. Estimated completion is 2004-10.
What conditions does trial NCT00864162 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00864162?
The interventions under investigation include: Ramipril10 mg Capsules, single dose (DRUG), Atlace® 10 mg capsules, single dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00864162?
This trial is sponsored by Actavis, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00864162 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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