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CompletedNCT05855187Updated May 11, 2023

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

A Phase 1 interventional study of Bravamax 200 mg (Modafinil) and Vigil 200 mg (Modafinil) in Healthy, sponsored by Genuine Research Center, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Genuine Research Center, Egypt · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2022, registered May 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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)

Read the detailed description

Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 24 healthy subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report Primary Pharmacokinetic Parameters: Cmax ,AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for log transformed (with the 90% confidence intervals) and untransformed data of Cmax,, AUC0→t and AUC0→∞and for untransformed data of Ke, tmax and t1/2e.

The confidence intervals of logarithmically transformed Test/Reference ratios for AUC0→t, AUC0→∞and Cmax to be within 80.00-125.00%.

A comprehensive final report will be issued upon the completion of the study.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Genuine Research Center, Egypt is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female, age 18 to 55 years, inclusive.
  2. 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).
  3. 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.
  4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
  5. Females should be on a suitable birth control method.
  6. Fully informed subjects that consented to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with known allergy to the products tested.
  2. Subjects who meet any of the contraindications to the administration of Modafinil.
  3. 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.
  4. Heavy smokers.
  5. Female subjects who were pregnant or nursing.
  6. Acute infection within one week preceding first study drug administration.
  7. History of drug or alcohol abuse.
  8. 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.
  9. Subject is on a special diet (for example subject is vegetarian).
  10. 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.
  11. 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.
  12. Subject has a family history of severe diseases which have direct impact on the study.
  13. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
  14. Subject intends to be hospitalized within 3 months after first study drug administration.
  15. Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    T test

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

    Drug: Bravamax 200 mg (Modafinil)

  • Active comparator
    R Reference

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

    Drug: Vigil 200 mg (Modafinil)

Interventions

06

What researchers measure

Primary outcomes

  1. Cmax

    to measure the maximal measured plasma concentration

    Time frame: Up to 72 hours post dose in each treatment period

Secondary outcomes

  1. Tmax

    time of the maximum plasma concentration

    Time frame: Up to 72 hours post dose in each treatment period

07

Study locations

1 site
  • Genuine Research Center GRC
    Cairo, 11757, Egypt
08

References and documents

Publications

  • 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. PubMed 11381568 ↗
  • 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. PubMed 3450848 ↗
  • 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. PubMed 2004861 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05855187
Collaborators
Chemipharm Pharmaceutical Industries, Egypt
Responsible party
Sponsor
First posted
May 11, 2023
Start date
Nov 15, 2022
Primary completion
Nov 22, 2022
Completion
Jan 10, 2023
Last update
May 11, 2023

Study contacts

Ahmed Elshafeey, Ph.D. Pharma
study director · Genuine Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Modafinil

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