Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition

Study Overview
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Brief Summary
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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.

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

Official Title
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Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Sirolimus Tablets 2 mg Under Fed Condition

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sirolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus tablets 2 mg<br>Sirolimus tablets 2 mg of Dr. Reddys Laboratories Limited | Drug: Sirolimus<br>* Sirolimus tablets 2 mg<br>* Other names: Rapamune;|
| Active Comparator: Rapamune<br>Rapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia | Drug: Sirolimus<br>* Sirolimus tablets 2 mg<br>* Other names: Rapamune;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) |  | 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. |