A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00870142
First received: March 26, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.


Condition Intervention Phase
Healthy
Drug: AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose
Drug: Norvasc® 10 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AMLODIPINE (as BESILATE) TABLETS 10 mg, single dose
Drug: AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fasting conditions
Other Names:
  • amlodipine besylate
  • amlodipine
Active Comparator: B
Norvasc® 10 mg Tablets, single dose
Drug: Norvasc® 10 mg Tablets
B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions
Other Names:
  • amlodipine besylate
  • amlodipine

Detailed Description:

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers under Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

  • Healthy adult male or female volunteers, 18-55 years of age;
  • Subject will be non-smokers or moderate smokers (less than 10 cigarettes a day) for at least 3 months.
  • Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 14 days following the last dose or be using one of the following acceptable birth control methods:

    1. surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
    2. IUD in place for at least 3 months.
    3. barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study, and for 14 days following the last dose.
    4. surgical sterilization of the partner (vasectomy for 6 months minimum).
    5. hormonal contraceptives for at least 3 months prior to the first dose of the study and for 14 days following the last dose.

      Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.

  • Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

  • Subject candidates must not be enrolled in the study if they meet any of the following criteria:
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • In addition, history or presence of:
  • alcoholism or drug abuse within the past year;
  • hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers.
  • Female subjects who are pregnant or lactating.
  • SUbjects who tested positive at screening for HIV, HbsAg or HeV.
  • Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
  • Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
  • Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
  • Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
  • Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
  • Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood In 14 days; 1500 mL of blood in 160 days; 2500 mL of blood In 1 year.
  • Subjects who have participated in another clinical trial within 28 days prior to the first dose.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870142

Locations
Canada, Quebec
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Gaetano Morelli,, MD MDS Pharma Services
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00870142     History of Changes
Other Study ID Numbers: 24308
Study First Received: March 26, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
amlodipine besylate
amlodipine
Healthy subjects

Additional relevant MeSH terms:
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 29, 2014