NCT00870142

CompletedPhase 1

A Relative Bioavailability Study of Amlodipine Besylate 10 m...

Actavis Inc.Source

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Other study identifiers

Sponsor study identifier

24308

Study Type

interventional

Actual enrollment (reported)

26

Locations

1 country

Sites

1

Timeline

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2005

Actual (reported)

Study Completion

May 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 26 participants
Study completion date: May 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2005
Actual (reported)
Study Completion
May 2005
Actual (reported)
First Submitted
March 26, 2009
Actual (reported)
First Posted
March 27, 2009
Actual (reported)

Last Updated: August 16, 2010
Status Verified: August 2010
Last Update Submitted: August 13, 2010

Conditions

Healthy

Keywords

Bioequivalenceamlodipine besylateamlodipineHealthy 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 doseDrug

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

Also known as: amlodipine besylate, amlodipine

A

Norvasc® 10 mg TabletsDrug

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

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Actavis Inc.
Industrylead

Study Sites (1)

MDS Pharma Services

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

MeSH Terms

Interventions

AmlodipineTablets

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

Gaetano Morelli,, MD
MDS Pharma Services
PRINCIPAL INVESTIGATOR

Enrollment

26 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00865085

A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions

Phase 1Completed

NCT00864149

A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Non-fasting Conditions

Phase 1Completed

NCT00871364

A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions

Phase 1Completed

NCT00871247

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions

Phase 1Completed

NCT00841815

Amlodipine 10 mg Tablets Under Fed Conditions

Phase 1Completed

NCT00864890

A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions

Phase 1Completed

Also known as: amlodipine besylate, amlodipine

B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

Primary Completion

May 2005

Actual (reported)

Study Completion

May 2005

Actual (reported)

Last Updated

August 16, 2010

Record last verified: 2010-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00870142
Data provider: ClinicalTrials.gov
Source updated: 2010-08-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:11 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations