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Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition

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. Identifier: NCT02296762
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Sirolimus Phase 1

Detailed Description:
Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Sirolimus Tablets 2 mg Under Fed Condition
Study Start Date : February 2010
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Sirolimus tablets 2 mg
Sirolimus tablets 2 mg of Dr. Reddys Laboratories Limited
Drug: Sirolimus
Sirolimus tablets 2 mg
Other Name: Rapamune

Active Comparator: Rapamune
Rapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia
Drug: Sirolimus
Sirolimus tablets 2 mg
Other Name: Rapamune

Primary Outcome Measures :
  1. Area under curve (AUC) [ Time Frame: predose (0.00) (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

i. Provide written informed consent

ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg

iii. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2

iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance)

v. Female Subjects

  • 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
  • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

i. Incapable of understanding the informed consent

ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg

iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg

iv. Oral temperature is below 95.0°F or above 98.6°F

v. Pulse rate below 50/min or above 100/min

vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs

vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function

viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period

ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period

x. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period

xi. Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period

xii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing

xiii. Clinically significant abnormalities and / or with significant diseases

xiv. Confirmed positive in alcohol screening

xv. Confirmed positive in selected drug of abuse

xvi. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study

xvii. Confirmed positive in urine pregnancy test

xviii. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02296762

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Bioserve Clinical Research Pvt. Ltd
Balanagar, Hyderabad, Andhra Pradesh, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Dr. Dwarakanath, MBBS Bioserve Clinical Research Pvt Ltd

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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT02296762    
Other Study ID Numbers: P-636/08
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: March 2010
Additional relevant MeSH terms:
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Nutrition Disorders
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs