Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)

NCT05855187 | Completed Phase 1

• 1 other identifier: GRC/1/22/1004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cmax

  to measure the maximal measured plasma concentration

  Up to 72 hours post dose in each treatment period

Secondary Outcomes (1)

• Tmax

  Up to 72 hours post dose in each treatment period

Study Arms (2)

T test

EXPERIMENTAL

1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water.

Drug: Bravamax 200 mg (Modafinil)

R Reference

ACTIVE COMPARATOR

1 tablet contains 200 mg Modafinil administrated according to a randomization scheme with 240 ml of water.

Drug: Vigil 200 mg (Modafinil)

Interventions

Bravamax 200 mg (Modafinil) DRUG

Test drug

Also known as: Vigil

T test

Vigil 200 mg (Modafinil) DRUG

Reference drug

Also known as: Vigil

R Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI) which is between (18.5-30.0).
• Medical demographics without evidence of clinically significant deviation from normal medical condition, eg: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Females should be on a suitable birth control method.
• Fully informed subjects that consented to participate in the study.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects who meet any of the contraindications to the administration of Modafinil.
• Subjects that do not agree not to consume alcohol-containing beverages and foods for 48 hours before dosing and throughout the period of sample collection.
• Heavy smokers.
• Female subjects who were pregnant or nursing.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not comply with the stated instruction of not taking 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 14 days prior to first study drug administration until the end of the study.
• Subject has a family history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.
• Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Chemipharm Pharmaceutical Industries, Egypt: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, 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

• 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

• 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

MeSH Terms

Interventions

Modafinil; FANG vaccine

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

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

Model Details: Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: November 15, 2022
• Primary Completion: November 22, 2022
• Study Completion: January 10, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)