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

NCT00870142 | Completed Phase 1

• 1 other identifier: 24308
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; amlodipine besylate; amlodipine; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  72 hours

Study Arms (2)

A

EXPERIMENTAL

AMLODIPINE (as BESILATE) TABLETS 10 mg, single dose

Drug: AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose

B

ACTIVE COMPARATOR

Norvasc® 10 mg Tablets, single dose

Drug: Norvasc® 10 mg Tablets

Interventions

AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose DRUG

A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fasting conditions

Also known as: amlodipine besylate, amlodipine

A

Norvasc® 10 mg Tablets DRUG

B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions

Also known as: amlodipine besylate, amlodipine

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
• IUD in place for at least 3 months.
• 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.
• surgical sterilization of the partner (vasectomy for 6 months minimum).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Montreal, Quebec, H4R 2N6, Canada

Location

MeSH Terms

Interventions

Amlodipine; Tablets

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gaetano Morelli,, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: April 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

CA (1)