Bioequivalence Study of [Follicle Stimulating Hormone (Human Recombinant)] Foligraf® 900 IU (66.0 mcg) / 1.5mL Solution for Injection in Healthy, Adult, Female, Human Subjects.

Not Applicable

• Registration Number: CTRI/2022/04/041980
• Lead Sponsor: Bharat Serums and Vaccines Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy premenopausal women volunteers of 18 to 40 years (both years inclusive) with BMI of 18.50 30 kg/m2 with minimum of 45 kg weight having regular menstrual periods (with a duration of 24-35 days) before initiation of study.

2. Normal or clinically non-significant ultrasound and gynaecological parameters.

3. Non-smoker and non-alcoholics.

4. Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable normal range.

5. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).

6. Subjects having clinically acceptable chest X-Ray (PA view), if taken.

7. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).

8. Subjects having negative alcohol breath test or urine alcohol test.

9. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

10. Subjects having negative urine pregnancy test at screening

11. Subjects having -hCG pregnancy test on day -71, on Day -15 and on admission day of period 01.

12. Subject who are willing to use acceptable contraceptive methods for 30 days after the last study drug administration.

13. Volunteers who can give written informed consent and communicate effectively.

14. Subjects complying below criteria: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), or abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam, or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

1. Hypersensitivity to r-hFSH, ethinylestradiol, levonorgestrel or gonadotropin preparations or gonadotropin releasing hormone (GnRH) analogues related class of drugs or any of its excipients or to heparin.

2. History or presence of significant cardiovascular, pulmonary, hepatic,renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

3. Clinically significant illness or surgery within 4 weeks prior to oral contraceptive pills distribution.

4. Subjects with serum FSH > 4 IU/L and serum Estradiol (E2) > 50 pg/mL at baseline (On check-in day of either period).

5. ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mm Hg, diastolic blood pressure lower than 50 or over 90 mm Hg, or heart rate less than 50 or over 100 bpm) at screening.

6. A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to oral contraceptive pills distribution.

7. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to oral contraceptive pills distribution.

8. Presence of alcoholism or drug abuse.

9. History or presence of asthma, urticaria or other significant allergic reactions.

10. History or presence of significant gastric and/or duodenal ulceration or gastrointestinal (GI) bleeding.

11. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.

12. History or presence of cancer or basal or squamous cell carcinoma.

13. Difficulty with donating blood.

14. Difficulty in swallowing solids like tablets or capsules.

15. Use of any prescribed medications and OTC medication [including herbal remedies, vitamins, preparations containing carotenoids] or vaccine within 30 days prior to oral contraceptive pills distribution.

16. Major illness within past 3 months prior to oral contraceptive pills distribution.

17. Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.

18. Consumption of xanthine-containing products, tobacco containing products or any alcohol product within 48 hours prior to admission of period 01.

19. Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to admission of period 01.

20. Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.

21. History or presence of significant easy bruising or bleeding.

22. History or presence of significant recent trauma.

23. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.

24. Female subjects who are currently pregnant or breast feeding or who are likely to become pregnant during the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare and evaluate the single-dose <br/ ><br>bioequivalence study of Foligraf® 900 IU (66.0 mcg) / 1.5mL Solution for Injection in Prefilled Pen [Follicle Stimulating Hormone (Human Recombinant)] of Bharat Serums and Vaccines Limited, India and GONAL-f 900 IU/1.5 mL solution for injection in pre-filled pen of Merck Serono in healthy adult female human subjects.Timepoint: A total of 25 blood samples will be collected for <br/ ><br>pharmacokinetic analysis during each study period. <br/ ><br>The pre-dose blood sample of 3.0 mL will be collected at -1.00, -0.50 and 00.00 hours prior to dosing and the post-dose blood samples of 3.0 mL will be drawn at 1.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 15.00, 16.00, 17.00, 18.00, 20.00, 24.00, 28.00, 32.00, 36.00, 42.00, 48.00, 72.00, 120.00 and 168.00 hours after dosing in each study period.

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of <br/ ><br>subjects.Timepoint: A total of 3 blood samples will be collected for anti-drug antibody analysis during study. The pre-dose blood sample of 3.0 mL will be collected at 00.00 hours (within 5 minutes before dosing) prior to dosing in eachperiod and the post-dose blood sample of 3.0 mL will be drawn at 168.00 hours after dosing period 02.