Status:
COMPLETED
Bioavailability of Clotiazepam 5 mg With Regards to Reference Product
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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. P...
Detailed Description
The primary objective of the study is to investigate the relative bioavailability of Clotiazepam of 1 tablet formulation with Clotiazepam 5 mg and to demonstrate bioequivalence of both formulations i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04440423
Start Date
March 11 2020
End Date
March 28 2020
Last Update
June 19 2020
Active Locations (1)
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1
Innolab
Santiago, Chile, 7510491