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 18 Fed, Healthy Adult Subjects

NCT00932880 | Completed Phase 1

• 1 other identifier: 20-061-SA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

• Objective:
• The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions.
• Study Design:
• This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.

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.
• 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 break smoking in the course of the study.
• No history of medication 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 objectives of the study.
• Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• Abnormal ECG.
• 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.
• Opioids and cannabis positive volunteers based on urine test.
• Subjects suffering from any psychiatric (acute or chronic) illness.
• Administration of any investigational drug in the period 0 to 3 months before entry to 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 for this study will not exceed 350ml.

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 16, 2009

Record last verified: 2009-07

Locations

US (1)