Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00828321
First received: January 12, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

The objective of this study is to compare the rate and extent of absorption of ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Ramipril 10 mg capsule
Drug: Altace® 10 mg capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized , 2- Way Crossover, Bioequivalence Study of Ramipril 10 mg Capsule and Altace® Administered as 1 x 10 mg Capsule in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ramipril 10 mg capsule
1 x 10 mg
Active Comparator: 2 Drug: Altace® 10 mg capsule
1 x 10 mg

Detailed Description:

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-childbearing potential female, light smoker of non-smoker 18 years of age and older.
  • Capable of consent
  • Non-childbearing potential female subject is defined as follows:
  • Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration, or
  • Surgically sterile: hysterectomy, bilateral oophorectomy, or tubule ligation at least 6 months prior to drud administration.

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the Medical Sub- Investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant, specifically BUN, serum creatinine and hyperkalemia.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • EcG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) or change in the systolic blood pressure of 20 mmHg, or diastolic blood pressure of 10mmHg when passing from supine (after at least 5 minutes) to standing position ( after 1-3 minutes), at screening.
  • BMI ≥30.0kg/m2.
  • History of significant alcohol abuse within 6 months prior to the screening visit of any indication of the regular use of more than 14 units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL of 40% hard alcohol), or positive alcohol breath test at screening.
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit of hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit of positive urine drug screen at screening.
  • History of allergic reactions to heparin, ramipril, or other ACE inhibitors, or other related drugs.
  • Use of any drugs known to induce hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoine, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of and investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver of kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of hte drug.
  • Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication ( including hormone replacement therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Difficulty to swallow study medication.
  • Smoking more than 10 cigarettes per day.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 300 mL of whole blood within 30 days,
  • 301 mL to 500 mL of whole blood within 45 days, or
  • more than 500 mL of whole blood within 56 days prior to drug administration.
  • Intolerance to venipunctures
  • Clinically significant history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will nor be eligible for this study.
  • Unable to understand or unwilling to sign the Informed Consent Form.
  • Clinically significant history of angioedema.
  • History of known presence of volume-depletion (diuretics, dialysis, gastrointestinal disease) or hypotension.
  • History of collagen-vascular disease and/or renal disease.
  • History of ischemic heart disease, congestive heart failure, or cerebrovascular disease.
  • Breast-feeding subject.
  • Positive urine pregnancy test at screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828321

Locations
Canada, Quebec
Anapharm Inc.
Montreal, Quebec, Canada, H2X 2H9
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Richard Larouche, M.D. Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00828321     History of Changes
Other Study ID Numbers: 40179
Study First Received: January 12, 2009
Results First Received: July 2, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalency
Healthy Volunteers

Additional relevant MeSH terms:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014