To evaluate Safety and Pharmacokinetics of Briogyn (Follitropin alfa, Cadila HealthCare)
- Registration Number
- CTRI/2020/12/029469
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
1Subjects who have used oral contraceptives for at least 3 months before study entry and are prepared to stop taking oral contraception from screening and to use effective non-hormonal methods of birth control until completion of 1 menstrual cycle after the last dose administration
2Women of child bearing potential must agree to use effective non-hormonal contraception for birth control until completion of 1 menstrual cycle after the last dose administration
3Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception
4Subjects with both ovaries
5Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission
6Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG)
7Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator
8Subjects who are able and willing to give written informed consent
1Subjects who do not conform to the above inclusion criteria
2Subjects with polycystic ovary syndrome
3Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size
4Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)
5Subjects with impaired thyroid function (treated or untreated)
6Subjects with a history of malignant disease
7Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range
8Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination)
9Subjects with a smoking history of more than 5 cigarettes per day
10Subjects with evidence of abuse of drugs or alcoholic beverages
11Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2
12Subjects who have participated in a clinical trial within the 3 months prior to this study
13Subjects who are unlikely to co-operate with the requirements of the study
14Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1
15Subjects who are pregnant, lactating or attempting to become pregnant
16Subjects with any medical condition (including a known predisposition to porphyria) that, in the opinion of the investigator, could interfere with safety of the subject or interfere with the objectives of the study
17Subjects who are vegans or have medical dietary restrictions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline Corrected rFSH Area Under the Serum Concentration- time Curve from Zero to the Last Quantifiable Measurement [AUC(0-last)]Timepoint: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.]
- Secondary Outcome Measures
Name Time Method Baseline Corrected rFSH Maximum Serum Concentration (Cmax)Timepoint: [Time Frame: From 0 hours (predose) to 192 hours postdose.]