Desogestrel Tablets (0.075 mg) Relative to Originator Desogestrel Tablets (0.075 mg)

Launched by BIO-INNOVA CO., LTD · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Desogestrel, which is used in birth control pills. The goal of the study is to compare a generic version of Desogestrel with the original branded version to see how well each is absorbed by the body when taken in the same dose. The trial will involve healthy women between the ages of 18 and 55, and participants will need to be willing to provide written consent and allow researchers to take a small sample of blood for safety monitoring after the study.

To be eligible for the trial, participants must be healthy and have a Body Mass Index (BMI) between 18.5 and 30. They should not have any significant medical conditions or a history of serious diseases, and women must not be pregnant or breastfeeding. During the trial, participants will take the medication twice, with a break of at least 28 days between doses, and they will be monitored closely for safety. It’s important to note that participants will need to avoid certain activities and substances, like drinking alcohol or smoking, for a specified time before and during the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Willingness to provide written informed consent prior to participate in the study.
• • 2. Healthy Thai female subjects are between 18 to 55 years of age.
• • 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
• • 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
• • 5. Negative urine pregnancy test for women and no breast-feeding.
• • 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
• Exclusion Criteria:
• • 1. History or evidence of allergy or hypersensitivity to Desogestrel or any related drugs or any of the excipients of this product.
• • 2. Subject with B.P. is Systolic B.P \< 90, ≥ 140 mm/Hg, Diastolic B.P \< 60, ≥ 90 mm/Hg, pulse rate \> 100 beats per minute.
• • 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).\*
• • 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).\*
• • 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).\*
• • 6. Positive of hepatitis B or C virus.
• • 7. Have more than one abnormal EKG, which is considered as clinically significant.\*
• • 8. History or evidence of heart (Myocardial infarction, Angina pectoris), renal, hepatic disease, pulmonary obstructive disease, vascular disease (DVT, PE, VT, stroke, TIA) bronchial asthma, hypertension, or glaucoma.
• • 9. History of abnormal vaginal bleeding or coagulopathy.5
• • 10. History of previous ectopic pregnancy, diabetes mellitus, depression, migraine.
• • 11. History or Family history of breast cancer, liver cancer and ovarian cyst.5
• • 12. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
• • 13. Any major illness in the past 3 months or any significant ongoing chronic medical illness.
• • 14. History of psychiatric disorder.
• • 15. History of regular alcohol consumption exceeding 7 drinks/week for females (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
• • 16. History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
• • 17. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
• • 18. History of grapefruit, pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
• • 19. History of St. John's Wort products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
• • 20. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine, Opioids and Barbiturates).
• • 21. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication.
• • 22. History of difficulty in accessibility of veins in left and right arm.
• • 23. Blood donation (one unit or 450 mL) within the past 3 months before the study.
• • 24. Participation in any clinical study within the past 3 months before the study.
• • 25. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
• • (\* Depend on decision of principal investigator and/or clinical investigator)