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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505998
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE January 5, 2012
First Posted Date  ICMJE January 9, 2012
Last Update Posted Date January 9, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
Bioequivalence is based on Cmax and AUC parameters [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fed
Intervention  ICMJE Drug: Amlodipine Besylate/Benazepril HCl
Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
Other Name: Lotrel
Study Arms  ICMJE
  • Experimental: Amlodipine Besylate/Benazepril HCl
    Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Dr. Reddy's Laboratories Ltd.
    Intervention: Drug: Amlodipine Besylate/Benazepril HCl
  • Active Comparator: Lotrel
    Lotrel® Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Novartis Pharmaceuticals
    Intervention: Drug: Amlodipine Besylate/Benazepril HCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2012)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505998
Other Study ID Numbers  ICMJE 5531/06-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Reddy's Laboratories Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: I. S. Gandhi., MD Vimta Labs Ltd.
PRS Account Dr. Reddy's Laboratories Limited
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP