Overview

Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

Status:
Completed
Trial end date:
2019-12-24
Target enrollment:
0
Participant gender:
Female
Summary
This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 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 14 days between each study period.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Laboratorios Andromaco S.A.
Treatments:
Dienogest
Nandrolone
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

- Non-smoking or smoke only 3 cigarettes every 7 days

- 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 or sponsor 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 a pharmacological therapy (except over the counter medication use 7 days
prior to the study)

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

- Use, during the 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 foods containing xanthines 24 hours before each
administration of the study medication until the last sample of each period

- History of any significant cardiovascular disease

- Acute disease that generates significant physiological changes from the time of
selection until the end of the study

- HIV, Hepatitis B and/or C positive

- Presence or history of thrombophlebitis, thrombosis or thromboembolic disorders, deep
vein thrombosis, pulmonary embolism or known coagulopathy.

- Donation or loss of a significant volume (more than 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