Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)

NCT04494191 | Completed Phase 1

• 1 other identifier: GRC/1/18/751
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximal measured plasma concentration

  Up to 48 hours post dose in each treatment period

Secondary Outcomes (1)

• Time of the maximum plasma concentration (Tmax)

  Up to 48 hours post dose in each treatment period

Study Arms (2)

T test

EXPERIMENTAL

Test drug (AphroFemine) 1 tablet contains 100 mg Flibanserin

Drug: Flibanserin 100Mg Tab

B reference

ACTIVE COMPARATOR

Reference drug (Addyi) 1 tablet contains 100 mg Flibanserin

Drug: Flibanserin 100 MG [Addyi]

Interventions

Flibanserin 100Mg Tab DRUG

One tablet contains 100 mg Flibanserin

Also known as: AphroFemine

T test

Flibanserin 100 MG [Addyi] DRUG

One tablet contains 100 mg Flibanserin

Also known as: Addyi

B reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy non pregnant females, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Subject does not have allergy to the drugs under investigation.
• Females should be on a suitable birth control method.

You may not qualify if:

• Males
• Subjects with known allergy to the products tested.
• Subjects whose values of BMI were outside the accepted normal ranges.
• Female subjects who were pregnant or nursing.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
• Subject is on a special diet (for example subject is vegetarian).
• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
• Subject has a history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Bio Med for Pharmaceuticals Industries (BIOMED), Egypt: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11511, Egypt

Location

Related Publications (3)

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

  PMID: 11381568 BACKGROUND

• Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

  PMID: 2004861 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

flibanserin

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: December 12, 2018
• Primary Completion: December 19, 2018
• Study Completion: February 27, 2019
• Last Updated: July 31, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)