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

NCT05135793 | Completed Phase 1

• 1 other identifier: GRC/1/20/896
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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)

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)

A test

EXPERIMENTAL

Test drug (Topoprazan) 1 tablet contains 20 mg vonoprazan

Drug: Topoprazan

B reference

ACTIVE COMPARATOR

Reference drug (Takecab) 1 tablets contains 20 mg vonoprazan

Drug: Takecab

Interventions

Topoprazan DRUG

1 tablet contains 20 mg vonoprazan

Also known as: Takecab

A test

Takecab DRUG

1 tablet contains 20 mg vonoprazan

B 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).
• 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.
• 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 7 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 has blood donated or lost more than 500 mL blood within 3 months prior to the study.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Hikma Pharma: 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

• 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

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: November 14, 2021
• First Posted: November 26, 2021
• Study Start: January 19, 2021
• Primary Completion: February 2, 2021
• Study Completion: March 1, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)