Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

Laboratorios Andromaco

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: Clotiazepam 5 mg Test Product Coated Tablets

Drug: Clotiazepam 5 mg Reference Product Coated Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT04440423

HP8810-02

Details and patient eligibility

About

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.

Full 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 in terms of rate and extent of absorption:

Test Product: Product manufactured by Tecnandina S.A., Ecuador.
Reference Product: Rize [Trademark], product of Mitsubishi Tanabe Pharma, Japan.

The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined.

Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 12 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 18 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 24 h and 34 h postdose.

The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma.

The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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