Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions

NCT00829452 | Completed Phase 1 Results

• 1 other identifier: 40181
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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 the content of 1 x 10 mg capsule mixed with applesauce under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.

  Bioequivalence based on Cmax.

  Blood samples collected over a 72 hour period.

• AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.

  Bioequivalence based on AUC0-t.

  Blood samples collected over a 72 hour period.

• AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.

  Bioequivalence based on AUC0-inf.

  Blood samples collected over a 72 hour period.

Secondary Outcomes (2)

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.

  Blood samples collected over a 72 hour period.

• AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.

  Blood samples collected over a 72 hour period.

Study Arms (2)

1

EXPERIMENTAL

Drug: Ramipril 10 mg capsule

2

ACTIVE COMPARATOR

Drug: Altace® 10 mg capsule

Interventions

Ramipril 10 mg capsule DRUG

1 x 10 mg

1

Altace® 10 mg capsule DRUG

1 x 10 mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (2)

Anapharm Inc.

Montreal, Quebec, H2X 2H9, Canada

Location

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Richard Larouche, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 27, 2009
• Study Start: August 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: August 19, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

CA (2)