Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 22 Fasted, Healthy Adult Subjects

NCT00932763 | Completed Phase 1

• 1 other identifier: 20-085-SA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

• Objective:
• The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects.
• Study Design:
• This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Interventions

Amlodipine besylate DRUG

10 mg tablets (Torrent Pharmaceuticals, India)

Norvasc DRUG

10 mg dose (Pfizer, USA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: Male/Female
• Age: 18 - 45 years.
• Volunteer with BMI of 18-27 kg/m2 with minimum of 50 kg weight.
• Volunteers with minimum blood pressure of 110/75 mmHg.
• Healthy and willing to participate in the study.
• Signed Written Informed Consent for Screening and study.
• Medical case history, physical examination, vital signs, laboratory tests and ECG without significant deviations.
• Negative drug of abuse screening test.
• Non-smokers or smoking less than 10 cigarettes a day and willing to refrain from smoking throughout the course of the study.
• No history of medication, prescription or OTC, for at least 2 weeks prior to study drug administration until study Period II completion.

You may not qualify if:

• Clinically relevant abnormal physical findings at the screening examination, which would interfere with the objective of the study.
• Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• Clinically relevant ECG abnormalities.
• Habituation of tobacco necessitating uninterrupted tobacco consumption.
• Addiction to alcohol or history of any drug abuse.
• History of kidney or liver dysfunction.
• History of allergy to the test drug or any drug chemically similar to the drug under investigation.
• Administration/Intake of any prescription or OTC medication for two weeks before the study.
• Patients suffering from any chronic illness such as arthritis, asthma etc.
• HIV, HCV, HBsAg positive volunteers.
• Positive test for drugs of abuse screen.
• Subjects suffering from any psychiatric (acute or chronic) illness.
• Administration of any investigational drug in the period 0 to 30 days before entry into the study.
• Intake of barbiturates or any enzyme-inducing drug in last three months.
• History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including anticipated blood loss for this study will exceed 1000 ml.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

CEDRA Clinical Research, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Last Updated: July 17, 2009

Record last verified: 2009-07

Locations

US (1)