Evaluation of the Bioavailability of Dexamethasone in Healthy Subjects

Launched by UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO · Dec 9, 2022

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Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
• • 1. Age: 18 - 35 years (inclusive)
• • 2. Health Status: Clinically healthy research subjects with the absence of clinically relevant abnormalities as identified by a medical history, physical examination, including determination of vital signs, a 12-lead electrocardiogram, and laboratory tests (which should be within normal values). allowed and corresponding validity, deviations will not be accepted)
• • 3. Have not consumed any medication 2 days before starting hospitalization.
• • 4. Signed and dated Informed Consent Form.
• • 5. Body mass index of 18 -27 Kg/m2.
• • 6. That it has been released from the COFEPRIS bioequivalence system database.
• • 7. Signed non-pregnancy commitment letter (by female subjects)
• Exclusion Criteria:
• Subjects presenting any of the following circumstances will not be included in the study:
• • 1. Clinical evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease or severe allergic reactions.
• • 2. Any condition that may affect the absorption of the drug. (ex. Gastrectomy, Sprue, etc.)
• • 3. Positive urine test for substances of abuse. Positive pregnancy test.
• • 4. Use of products containing tobacco or nicotine 72 hours before and for the entire duration of the study.
• • 5. Smoker (No more than 1 cigarette per day) or who has difficulty abstaining from tobacco consumption 72 hours before and for the entire duration of the study.
• • 6. History of frequent excessive alcohol consumption 7 drinks per week for female subjects or 14 drinks per week for male subjects (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 4 months prior to the canvass.
• • 7. Alcohol consumption before (48 hours) and during the study. (For this purpose, a breath test will be carried out with a breathalyzer prior to the start of each session).
• • 8. Consumption of food or beverages that contain grapefruit and/or grapes or citrus fruits related to grapefruit (citrus) as well as carbonated foods or vegetarian diet or chocolate or coffee, from 3 days before the start of the study and until the last sample has been obtained.
• • 9. Study drug treatment 30 days prior.
• • 10. History of hypersensitivity to the study drug or its derivatives.
• • 11. History of heparin sensitivity or heparin-induced thrombocytopenia.
• • 12. A 12-lead resting EKG demonstrating a QTc of \>450 msec at the time of screening. If the QTc exceeds 450 msec, the test should be repeated twice and the average of the three tests relative to the QTc should be used to determine subject eligibility (in the presence of clinical pathology findings).
• • 13. Being participating in another study or having participated in another study without having elapsed at least the time equivalent to 7 half-lives of the drug administered in the previous study or without having elapsed 3 months. (whatever happens next)
• • 14. Presence of use of prescription or non-prescription medications, dietary supplements, pre-study or herbal supplements, and hormonal methods of contraception (including oral, transdermal, injectable contraceptives, injectable progesterone, progestin implants). Women are expected to take appropriate precautions to prevent pregnancy and fetal exposure to a potentially toxic agent for the duration of the study (from the screening visit to the end of the study). Women of childbearing age will be informed that they must take the appropriate measures to prevent pregnancy during the study, such as the following: a) Willing to maintain abstinence (not having sexual intercourse) from 14 days before the start of the study to 28 days after the start of the study. end of study or b) Be willing to use two effective methods of birth control (condom, diaphragm, cervical cap, vaginal sponge, spermicides, non-hormonal IUD, tubal ligation, partner with vasectomy). Either of the two options from 14 days before the start of the study and up to 28 days after its conclusion. In no case may a lactating female subject participate.
• • 15. Blood donation approximately 1 unit (500 mL) in a period of less than 90 days before the first study session.
• • 16. Inability or refusal to comply with the indications described in this protocol.
• • 17. Any other acute or chronic, medical or psychiatric, or laboratory condition that may increase the risk associated with the participation of the product to be administered or that may interfere with the interpretation of the study results and, in the Investigator's opinion, may compromise the participation of the subject in the study, including any type of recent hospitalization (1 month).
• • 18. Results outside the normal values for the hematological, biochemical and laboratory tests carried out in the selection phase.
• • 19. Subjects who have ingested a drug that induces or inhibits metabolism within the last two weeks prior to the study.