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CompletedNCT05135793Updated Nov 26, 2021

Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)

A Phase 1 interventional study of Topoprazan and Takecab 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 2021-11-26.

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

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2021, registered Nov 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)

Read the detailed description

Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 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 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 Cmax, AUC0→t and AUC0→∞ 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 36 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

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).
  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. Female subjects who were pregnant or nursing.
  3. Acute infection within one week preceding first study drug administration.
  4. History of drug or alcohol abuse.
  5. 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.
  6. Subject is on a special diet (for example subject is vegetarian).
  7. 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.
  8. 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.
  9. Subject has a family history of severe diseases which have direct impact on the study.
  10. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
  11. Subject intends to be hospitalized within 3 months after first study drug administration.
  12. Subjects who has 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
29 participants (actual)

Study arms

  • Experimental
    A test

    Test drug (Topoprazan) 1 tablet contains 20 mg vonoprazan

    Drug: Topoprazan

  • Active comparator
    B reference

    Reference drug (Takecab) 1 tablets contains 20 mg vonoprazan

    Drug: Takecab

Interventions

  • DrugTopoprazan

    1 tablet contains 20 mg vonoprazan

    Also known as: Takecab

  • DrugTakecab

    1 tablet contains 20 mg vonoprazan

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximal measured plasma concentration

    Time frame: up to 48 hours post dose in each treatment period

Secondary outcomes

  1. Time of the maximum plasma concentration (Tmax)

    The amount of time that a drug is present at the maximum concentration in serum

    Time frame: Up to 48 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. Erratum In: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101. PubMed 11381568 ↗
  • 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 ↗
  • 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 ↗

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 Nov 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05135793
Lead sponsor
Genuine Research Center, Egypt
Collaborators
Hikma Pharma
Responsible party
Sponsor
First posted
Nov 26, 2021
Start date
Jan 19, 2021
Primary completion
Feb 2, 2021
Completion
Mar 1, 2021
Last update
Nov 26, 2021

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 ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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