Overview

Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition

Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
All
Summary
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 fasting conditions - monitor adverse events and to ensure the safety of subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Simvastatin
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.