Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01167933
First received: July 21, 2010
Last updated: August 5, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to

  • compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions
  • monitor adverse events and to ensure the safety of subjects.

Condition Intervention Phase
Healthy
Drug: Simvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Simvastatin 80 mg Tablets of Dr. Reddy's to be Compared With Zocor® 80 mg Tablets of Merck & Co. Inc., USA in Healthy Adult Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin
Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd.
Drug: Simvastatin
Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Other Name: Zocor® 80 mg tabletsof Merck & Co. Inc., USA
Active Comparator: Zocor
Zocor® 80 mg tablets of Merck & Co. Inc., USA
Drug: Simvastatin
Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Other Name: Zocor® 80 mg tabletsof Merck & Co. Inc., USA

Detailed Description:

A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck & Co. Inc., USA in healthy, adult, human subjects under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will provide written informed consent.
  • Subjects must be healthy adults within 18-45 years of age (inclusive) weighing at least 50 kg.
  • Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
  • Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior' to the commencement of the study.
  • Have normal ECG, 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, or abstinence.
    • is postmenopausal for at least 1 year.
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) No female volunteers turned up to the site for participating in the study.

Exclusion Criteria:

Bioequivalence studies are usually conducted in healthy adult subjects in order to assess and compare the pharmacokinetic profile of test and reference formulations under uniform conditions. Therefore it is essential to exclude those subjects who show abnormalities with respect to their health parameters. Subjects were excluded to participate in the study based on certain criteria. These criteria were made in order to safeguard the health of the subjects enrolled into the study.

  • Subjects incapable of understanding the informed consent.
  • Subjects with BP≤90/60 or BP≥140/90
  • History of hypersensitivity or idiosyncratic reaction to Simvastatin.
  • Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal, endocrine, immunologic, neurologic and haematologic function.
  • 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 start of clinical period.
  • 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 tested positive at screening for Human Immunodeficiency Virus, Hepatitis B Surface Antigen or Hepatitis C Virus
  • Subjects with positive urine screen for drugs of abuse.
  • Any subject in whom Simvastatin is contraindicated for medical reasons.
  • Subjects who have used any drugs or substances such as herbal preparations known to be strong inhibitors of CYP.enzymes (formerly known as cytochrome P450 enzymes) within 14 days prior to the first dose.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are-currently breast-feeding. No female volunteers reported to study site for participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167933

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mangesh Kulkarni Vimta Labs Limited, Hyderabad, India, 500 051
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan / Vice President (Research and Development), Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01167933     History of Changes
Other Study ID Numbers: 8340
Study First Received: July 21, 2010
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Simvastatin

Additional relevant MeSH terms:
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014