HealthyPhase 1NCT02756936
Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
A Phase 1 study testing Daclatasvir Zeta and Clatazev in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
Trial summary
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daclatasvir Zeta and Clatazev
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- Subject does not have allergy to the drugs under investigation.
Who cannot join
- Subjects with known allergy to the products tested.
- Subjects whose values of BMI were outside the accepted normal ranges.
- Female subjects who were pregnant, nursing or taking birth control pills.
- Medical demographics with evidence of clinically significant deviation from normal medical condition.
- Results of laboratory tests which are clinically significant.
- Acute infection within one week preceding first study drug administration.
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- History of drug or alcohol abuse.
- Subject does not agree not to take 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 history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drug administration.
- Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition.
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Daclatasvir Zeta, Clatazev
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclatasvir ZetaDrug
Also called Daklinza
1 tablet contains 60 mg Daclatasvir
ClatazevDrug
Also called Daklinza
1 tablet contains 60 mg Daclatasvir
| Study group | Role | What they receive |
|---|---|---|
| A Test | Experimental | Test drug (Daclatasvir zeta)1 tablet contains 60 mg Daclatasvir Receives: Drug: Daclatasvir Zeta |
| B Reference | Active comparator | Reference drug (Clatazev)) 1 tablet contains 60 mg Daclatasvir Receives: Drug: Clatazev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal measured plasma concentration (Cmax)
Serial blood samples for determination of study drug will be collected at 0.00, 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00, 72.00 hrs
Measured: Up to 72 hours post dose in each treatment period
Secondary outcomes (1)
Time of the maximum plasma concentration (Tmax)
he amount of time that a drug is present at the maximum concentration in serum
Measured: Up to 72 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genuine Research Center, Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zeta Pharma Pharmaceutical Industries
- Responsible party
- Sponsor
- Investigators
- Ahmed Elshafeey, Ph.D. Pharma, Study director, Genuine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756936
- Sponsor's protocol ID
- GRC/1/16/600
- Status last verified
- Feb 2017
- First submitted
- 28 Apr 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 11381568Diletti 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 2004861Schuirmann 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT02756936
- Acronym / sponsor ID
- GRC/1/16/600
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
- Collaborators
- Zeta Pharma Pharmaceutical Industries
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Test | Experimental | Drug: Daclatasvir ZetaTest drug (Daclatasvir zeta)1 tablet contains 60 mg Daclatasvir |
| B Reference | Active comparator | Drug: ClatazevReference drug (Clatazev)) 1 tablet contains 60 mg Daclatasvir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- Subject does not have allergy to the drugs under investigation.
Key exclusion criteria (15 listed)
- Subjects with known allergy to the products tested.
- Subjects whose values of BMI were outside the accepted normal ranges.
- Female subjects who were pregnant, nursing or taking birth control pills.
- Medical demographics with evidence of clinically significant deviation from normal medical condition.
- Results of laboratory tests which are clinically significant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclatasvir ZetaAlso: Daklinza1 tablet contains 60 mg Daclatasvir | Drug | A Test |
| ClatazevAlso: Daklinza1 tablet contains 60 mg Daclatasvir | Drug | B Reference |
Primary outcome
Maximal measured plasma concentration (Cmax)
Time frame: Up to 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected at 0.00, 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00, 72.00 hrs
1 secondary outcome
Time of the maximum plasma concentration (Tmax)
Time frame: Up to 72 hours post dose in each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Background: PubMed 11381568Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
- Background: PubMed 2004861Diletti 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.
- Background: PubMed 3450848Schuirmann 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.
- International conference of Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elshafeey, Ph.D. Pharma study director
Genuine Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daclatasvir Zeta and Clatazev in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal measured plasma concentration (Cmax) (time frame: Up to 72 hours post dose in each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.