Open-label, randomized, single dose, two-period, two-treatment cross-over bioequivalence study of Dienogest 2 mg tablets from Naari Pharma Pvt. Ltd. - India vs Visanne 2 mg tablets, from Bayer Weimar GmbH UND Co.KG, Weimar, Germany in healthy female subjects under fasting conditions
- Conditions
- Healthy subjectsBioequivalenceDienogest 2 mg
- Registration Number
- TCTR20220906003
- Lead Sponsor
- Abbott Laboratories Limited, Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Unknown
- Sex
- Female
- Target Recruitment
- 44
Normal females, of of 18-55 years of age with body mass index in the range of 18.50 - 30.00 kg/m2
Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study
Willing to take appropriate measures to prevent pregnancy during the study, such as total abstinence from sexual activities or the use of condom for at least 14 days prior to dosing period I and willing to continue until 1 week from end of the study.
Willing to be available for the entire study period and to comply with protocol requirements
Normal health status is to be determined by baseline medical and medication history, at the time of screening and vital signs (sitting blood pressure, pulse rate, respiratory rate and forehead-surface temperature) measurements and clinical examination at the time of screening as well as at check-in during each study period
With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis
With a normal or clinically non-significant 12-lead Electrocardiogram (ECG)
Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
Able to communicate effectively with study personnel
Non-alcoholic [i.e. alcohol consumption not exceeding 7 drinks/week (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 24 hours before the study drug administration and until the completion of each period of the study.
For subjects who still have a uterus
oNegative urine pregnancy test during screening and each period before dosing
Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, obstetrics and gynecological history along with breast examination that showed sign of significant disease]
Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood-forming organs
History of allergy or hypersensitivity intolerance to Dienogest or its formulation excipients
Significant history or presence of sign and symptoms of arterial and cardiovascular disease (e.g., myocardial infarction, Cerebrovascular accident, ischemic heart disease), ophthalmic vascular disease, diabetes mellitus with vascular involvement, severe hepatic disease as long as liver function values have not returned to normal, active venous thromboembolic disorder, liver tumors (benign or malignant), known or suspected sex hormone-dependent malignancies, undiagnosed abnormal vaginal bleeding, migraine with focal aura, depression, bronchial asthma
Any present disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system
History or presence of significant easy bruising or bleeding
Any major illness or hospitalized within 90 days prior to the first dosing
Any other clinical condition like diarrhea or vomiting within 3 days prior to first dosing
History or presence of significant gastric and/or duodenal ulceration within past 1 year prior to first dosing
History of any gastrointestinal disease which could affect drug absorption
Use of any hormone replacement therapy within 3 months prior to the first dose of study medication
Use of any depot injection or an implant of any drug within 6 months prior to first dosing and throughout the study periods
Use of any prescribed medication 14 days or within 5 half-lives (whichever longer) of the drug, whichever is longer prior to first dose of study medication
Use of any OTC products (including herbal drugs and vitamin supplements) within 7 days or within 5 half-lives of the drug, whichever is longer prior to the first dose of study medication
Subjects who have received a known Investigational drug within ten elimination half-life of the administered drug prior to the first dose of study medication
Subjects who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater
A positive hepatitis screen (includes subtypes B & C) and HIV antibody
Use of any recreational drug or history of drug addiction
History or evidence of drug dependence or of alcoholism or of moderate alcohol use
Consumption of alcohol or alcoholic products within 24.00 hrs prior to dosing of each period of the study
Positive alcohol breath or urine drug of abuse tests during check-in in each study period
History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture
Difficulty in swallowing solids like tablets or capsules
Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the subject's participation in this study
Consumption of xan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-inf, and AUC0-t 0.000, 0.167, 0.250, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.500, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety; Adverse events 1.0, 2.0, 4.0, 6.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours Safety; Adverse events Safety monitoring, vital sign