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Comparative Pharmacokinetics of AFOLIA and US Gonal-f� RFF Redi-ject After Single Subcutaneous Application

Information source: Finox AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Afolia (Drug); US Gonal-f® (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Finox AG

Overall contact:
Olufeyikemi Oluwayi, MD, Phone: +44 (0) 207 910 7718, Email: Olufeyikemi.oluweyi@quintiles.com

Summary

Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

Clinical Details

Official title: Comparative Pharmacokinetics of AFOLIA and US Gonal-f RFF Redi-ject After Single Subcutaneous Application. A Randomised, Open Label, 2-way Cross-over Study

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Equivalence of the baseline corrected Area under the Curve (AUC) for FSH serum concentration after AFOLIA and US Gonal-f® application

Secondary outcome:

Assessment of FSH baseline corrected Cmax of AFOLIA compared to US Gonal-f®

Assessment of FSH baseline corrected Tmax AFOLIA compared to US Gonal-f®

Assessment of FSH baseline corrected t1/2ß of AFOLIA compared to US Gonal-f®

Assessment of the baseline corrected E2 serum exposure concentration (AUC) after a single administration of AFOLIA compared to US Gonal-f®

Assessment of the baseline corrected E2 Cmax after a single administration of AFOLIA compared to US Gonal-f®

Assessment of the baseline corrected E2 Tmax after a single administration of AFOLIA compared to US Gonal-f®

Eligibility

Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of 18. 0 to 32. 0 kg/m2 (inclusive) 2. Subjects 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 3. Women 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 4. Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception 5. Subjects with both ovaries 6. Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission 7. Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG) 8. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator 9. Subjects who are able and willing to give written informed consent Exclusion Criteria: 1. Subjects who do not conform to the above inclusion criteria 2. Subjects with polycystic ovary syndrome 3. Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size 4. Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome) 5. Subjects with impaired thyroid function (treated or untreated) 6. Subjects with a history of malignant disease 7. Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range 8. Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination) 9. Subjects with a smoking history of more than 5 cigarettes per day 10. Subjects with evidence of abuse of drugs or alcoholic beverages 11. Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2 12. Subjects who have participated in a clinical trial within the 3 months prior to this study 13. Subjects who are unlikely to co-operate with the requirements of the study 14. Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to

study day - 1

15. Subjects who are pregnant, lactating or attempting to become pregnant 16. Subjects 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 17. Subjects who are vegans or have medical dietary restrictions 18. Subjects who cannot communicate reliably with the investigator

Locations and Contacts

Olufeyikemi Oluwayi, MD, Phone: +44 (0) 207 910 7718, Email: Olufeyikemi.oluweyi@quintiles.com

London, United Kingdom; Recruiting
Olufeyikemi Oluwayi, MD, Phone: +44 (0) 207 910 7718, Email: Olufeyikemi.oluweyi@quintiles.com
Additional Information

Starting date: May 2015
Last updated: May 28, 2015

Page last updated: August 23, 2015

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