Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions

An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Under Fed Conditions

The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.

Study Overview

• Status: Completed
• Conditions: Fed
• Intervention / Treatment: Drug: Amlodipine Besylate/Benazepril HCl

Detailed Description

An open-label randomized, single dose, two way crossover oral bioequivalence study to compare Amlodipine Besylate/Benazepril Hydrochloride 10 mg/40 mg capsules (Dr. Reddy's Laboratories Ltd.,) with Lotrel® capsules Novartis Pharmaceuticals Corporation in healthy human subjects under fed conditions.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • A.P
    • Hyderabad, A.P, India, 500 051
      • Vimta Labs Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will provide written informed consent.
• Subjects must be healthy adults within 18-45 years of age (inclusive).
• Body mass index of ≥18 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg.
• Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period I.
• Have normal ECG, Chest X-ray and vital signs.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.

or is postmenopausal for at least 1 year. or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

•Each female subject will be given a urine pregnancy test at check-in for period-I, period-II and post study.

Exclusion Criteria:

• Subjects incapable of understanding the informed consent.
• Subjects with BP ≤90/60 mm/Hg or BP ≥140/90 mm/Hg
• History of hypersensitivity or idiosyncratic reaction to Amlodipine Besylate/Benazepril Hydrochloride or any other related drug.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years),diabetes, psychosis or glaucoma will not be eligible for the study
• Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
• Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to dosing in Period-I.
• History of any psychiatric illness, which may impair the ability to provide written, informed consent.
• Subjects who have a history of alcohol or substance abuse within the last 5 years
• Subjects with clinically significant abnormal values of laboratory parameters.
• Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• Subjects who are unable to or likely to be non-compliant with protocol requirements or restrictions.
• Any subject in whom Amlodipine Besylate /Benazepril Hydrochloride is contraindicated for medical reasons
• Subjects who are intolerant to venipuncture
• Subjects with positive urine screen for drugs of abuse. All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate
• Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing
• Female volunteers demonstrating a positive pregnancy screen.
• All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study
• Female volunteers who are currently breast feeding.
• Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlodipine Besylate/Benazepril HCl; Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Dr. Reddy's Laboratories Ltd.	Drug: Amlodipine Besylate/Benazepril HCl; Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules; Other Names: Lotrel
Active Comparator: Lotrel; Lotrel® Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Novartis Pharmaceuticals	Drug: Amlodipine Besylate/Benazepril HCl; Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules; Other Names: Lotrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence is based on Cmax and AUC parameters	3 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: I. S. Gandhi., MD, Vimta Labs Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 6, 2012
• First Posted (Estimate): January 9, 2012

Study Record Updates

• Last Update Posted (Estimate): January 9, 2012
• Last Update Submitted That Met QC Criteria: January 6, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Amlodipine; Benazepril
• Other Study ID Numbers: 5531/06-07