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Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05860530
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
4
Actual Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: The test olaparib tablet (T)
  • Drug: The reference olaparib tablet (R)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Sep 8, 2021
Actual Study Completion Date :
Sep 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Test-reference

Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.

Drug: The test olaparib tablet (T)
The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours

Drug: The reference olaparib tablet (R)
The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours
Other: Reference-test

Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.

Drug: The test olaparib tablet (T)
The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours

Drug: The reference olaparib tablet (R)
The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours

Outcome Measures

Primary Outcome Measures

  1. Cmax,ss [Day 7]

    The maximum plasma drug concentration at steady state

  2. AUC0-τ [0-12 hours]

    The area under the concentration-time curve between two dosings at steady state

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Had BMI 18.0 kg/m^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female

  • Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators

  • Had ECOG performance status 0-1

  • Had life expectancy >12 weeks

  • Had Adequate organ function or clinically irrelevant abnormal result

  • Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose

Exclusion Criteria:

  • Allergic to any component of study drugs

  • Had central nervous system metastases (stable and asymptomatic metastases were acceptable)

  • Had other malignancy within 5 years

  • Had disease affecting swallow or absorption

  • Received major surgery within 1 month before study drug administration

  • Had major disease

  • Had continuous grade 3-4 adverse event

  • Had drug abuse

  • Had (suspected) pneumonitis

  • Participated in other clinical trial of drug or device within 1 month

  • Lost or donated blood > 200 mL or received blood transfusion within 1 month

  • With average alcohol consumption > 14 units/week or cigarette consumption > 20/day within 1 month

  • Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug

  • Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine

  • For female, pregnant or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05860530
Other Study ID Numbers:
  • QL-YK3-052-001
First Posted:
May 16, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Olaparib

Study Results

No Results Posted as of May 17, 2023