Clinical trial: Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition (NCT01080469)

Eligibility criteria:
Inclusion Criteria:

          1. Male subjects in the range of age from 18 to 55 years.

          2. Body weight within ± 15% of ideal weight as related to height and body frame according
             to Life Insurance Corporation (LIC) Chart. (Appendix A)

          3. Subjects with normal findings as determined by baseline history, physical examination
             and vital signs (blood pressure, pulse rate, respiration rate and axillary
             temperature).

          4. Subjects with normal findings as determined by Haemogram with ESR,
             Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and
             Urinalysis, ECG, X-ray (X-ray if taken).

          5. Willingness to follow the protocol requirement as evidenced by written, informed
             consent.

          6. Agreeing to, not using any medication prescription and over the counter medications
             including vitamins and minerals for 14 days prior to study & during the course of the
             study.

          7. No history or presence of significant alcoholism or drug abuse in the past one year.

          8. Non-smokers, ex smokers and moderate smokers will be included. "Moderate smokers are
             defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who
             completely stopped smoking for at least 3 months."

        Exclusion Criteria:

          1. Requiring medication for any ailment including enzyme-modifying drugs in the previous
             28 days, before day 1 of dosing.

          2. Any medical or surgical conditions, which might significantly interfere with the
             functioning of gastrointestinal tract, blood-forming organs etc.

          3. History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary,
             neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or
             psychiatric diseases.

          4. Participation in a clinical drug study or bioequivalence study 90 days prior to
             present study.

          5. History or presence of malignancy or other serious diseases.

          6. Refusal to abstain from food for at least ten (10) hours prior to administration of
             the study drug and for four (4) additional hours each, post dose during each study
             period.

          7. Any contraindication to blood sampling.

          8. Refusal to abstain from water for at least one (1) hour prior to study drug
             administration on dosing day of each study period and for at least two (2) additional
             hours, post dosing except 240 mL administered during administration of the dose.

          9. Use of xanthine-containing beverages or food and grapefruit or grapefruit products for
             48 hours prior to each drug dose.

         10. Blood donation 90 days prior to the commencement of the study.

         11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.

         12. Subjects having contradiction or hypersensitivity to Tacrolimus or related group of
             drugs or any excipients of the products.

         13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
             dosing until last sample collection of each period.

         14. Found positive in Breath alcohol test done at the time of screening or on the day of
             enrollment for each study period or for every ambulatory sample.

         15. History or presence of problem in swallowing tablets or capsules.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Contradiction