Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

• Status: Completed
• Trial end date: 2020-03-28
• Target enrollment: 0
• Participant gender: All

Summary

This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet formulations containing Clotiazepam 5 mg.

The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 Tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Andromaco S.A.

Criteria

Inclusion Criteria:

• Non-pregnant and non-breastfeeding women

• Women of childbearing age with an acceptable form of contraception during the study

• 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99

• With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination

• Capable to understand the Informed Consent Form

Exclusion Criteria:

• Study Site staff or family members

• With history of drug and/or alcohol abuse

• Smokers more tan 3 cigarettes every 7 days

• Vitamin supplements intake 7 days prior to the administration of the medications under study

• Any recent change in eating habits or physical exercise

• Using of pharmacological therapy (except over the counter medication use 7 days prior the study)

• Hypersensitivity to the study drug or other related compounds, history of serious adverse reactions or hypersensitivity to any medication

• Use, during 28 days prior to the start of the study, of medications known to alter liver enzyme activity

• Consumption of beverages or food containing grapefruit or pink grapefruit, within 7 days prior to each administration of the study medication and consumption of alcohol, caffeine or beverages or food containing xanthine 24 hours prior each administration of study medication until the last sample of each period

• History of any significant cardiovascular disease

• Acute disease that generates significant physiological changes from the start of the selection until the end of the study

• HIV, Hepatitis B and/or C positive

• Presence or history of thrombophlebitis, thrombosis or thromboembolic disorder, deep vein thrombosis, pulmonary embolism or known coagulopathy.

• Donation or loss of a significant volume (more tan 100 mL) of blood or plasma or platelets during the 3 months prior to the start of the study

• Subjects who have participated in any type of clinical study during the 3 months prior to the start of the study

• History of any gastrointestinal surgery that could affect drug absorption

• Presence of fainting history or fear to blood collection