Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting Condition

NCT02296749 | Completed Phase 1 DMC

• 1 other identifier: P-635/08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 Fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  predose (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.

Study Arms (2)

Sirolimus tablets 2 mg

EXPERIMENTAL

Sirolimus tablets 2 mg of Dr. Reddys Laboratories Limited

Drug: Sirolimus

Rapamune

ACTIVE COMPARATOR

Rapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia

Drug: Sirolimus

Interventions

Sirolimus DRUG

Sirolimus tablets 2 mg

Also known as: Rapamune

Rapamune; Sirolimus tablets 2 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• i. Incapable of understanding the informed consent
• ii. Systolic blood pressure less than 90 mm of 140 mm of Hg
• iii. Diastolic blood pressure less than 60 mm of 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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Pvt. Ltd

Balanagar, Hyderabad, Andhra Pradesh, 500 037, India

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Dr. Dwarakanath, MBBS

  Bioserve Clinical Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 20, 2014

Record last verified: 2010-03

Locations

IN (1)