HealthyPhase 1BABENCT04877834
Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
A Phase 1 study testing Dexlansoprazole in people with Healthy and Bioequivalence Study, run by University of Karachi at 1 site in Pakistan.
Trial summary
Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Bioequivalence Study
- What is being tested?
- Dexlansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Sep 2021to 25 Nov 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18 to 55 years inclusive.
- Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
- Subject is able to fast for 14 hours and consume standard meals.
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (morphine \& cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects who are able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
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- Subject agreed not to consume food or beverages including tea, coffee, cola drinks, chocolates containing xanthine derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until last blood draw in each study period.
- Subject agreed not to intake prescription drugs (especially any other PPI, Antiretroviral (e.g. rilpivirine, atazanavir and nelfinavir), Warfarin, clopidogrel, methotrexate, drugs dependent on gastric pH for absorption, etc.) within 14 days or 5 half-lives (whichever is longer) prior to first dose of study medicine.
- Subject agreed not to intake non-prescription drugs (OTC) within 14 days prior to first dose of study medicine.
- Subject agreed to discontinue vitamins, dietary and herbal supplements within 14 days prior to the first dose of study medication.
- Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
Who cannot join
- Subjects who refused to sign Informed Consent Form.
- Inability to take oral medication.
- Pregnant and lactating females.
- History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subjects allergic to Dexlansoprazole and/or other Antacid drugs.
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- Subject has received any investigational drug within four weeks.
- Participated in any clinical trials within 3 months.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- History of any significant illness in the last four weeks which might confound in the result of the study or post additional risk in administrating Dexlansoprazole to the subject.
- Subjects tested positive for syphilis (VDRL) or is known to have serum hepatitis or carrier of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Subject tested positive for COVID-19 or is known to have such family members who tested positive for COVID-19 in recent times.
- Subject has undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
- Subject has a condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.
- A heart rhythm disorder (especially if you take medication to treat it) or history of long QT syndrome.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and clinical research
Karachi, Sindh, 75270
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.
Read the detailed description
Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood samples will be taken up to 24 hours post dose for the calculation of Cmax, Tmax, AUC.
- Conditions
- Healthy, Bioequivalence Study
- Being tested
- Dexlansoprazole
- Keywords
- Bioequivalence Study, Healthy Pakistani Population,, Dexlansoprazole Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called DelanzoTMDR 60 mg capsule, hard
Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.
DexlansoprazoleDrug
Also called Dexilant® 60 mg capsule, hard
Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.
| Study group | Role | What they receive |
|---|---|---|
| DelanzoTMDR group | Experimental | Subjects will take DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd. after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point. Receives: Drug: Dexlansoprazole |
| Dexilant® Group | Active comparator | Subjects will take Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point. Receives: Drug: Dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Determination of plasma drug concentration
Measured: 24 hours
Tmax
Time to reach maximum plasma drug concentration
Measured: 24 hours
AUC
Area under the Plasma concentration Versus time curve
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start18 Sep 2021
- Primary completion25 Oct 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A single center, open-label, randomized, single-dose, two-period, two-way, cross-over study.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd.
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Prof. Dr. Muhammad R Shah, PhD, Principal investigator, Center for bio-equivalence, and clinical research, university of karachiDr. Naghma Hashmi (Co-PI), PhD, Principal investigator, Center for bio-equivalence, and clinical research, university of karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877834
- Sponsor's protocol ID
- CB-035-DEX(D)-2020
- Acronym
- BABE
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will only be available upon reasonable request to PI, subject to the confidentiality of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
- ClinicalTrials.gov ID
- NCT04877834
- Acronym / sponsor ID
- BABE / CB-035-DEX(D)-2020
- Conditions
- Healthy, Bioequivalence Study
- Keywords
- Bioequivalence Study, Healthy Pakistani Population,, Dexlansoprazole Capsule
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd.
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 7 May 2021 (actual)
- 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.
Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.
Detailed description
Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood samples will be taken up to 24 hours post dose for the calculation of Cmax, Tmax, AUC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single center, open-label, randomized, single-dose, two-period, two-way, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| DelanzoTMDR group | Experimental | Drug: DexlansoprazoleSubjects will take DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd. after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point. |
| Dexilant® Group | Active comparator | Drug: DexlansoprazoleSubjects will take Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited after at least 10 hours' fast, with 240 mL of ambient temperature water at their scheduled dosing time-point. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy subjects aged 18 to 55 years inclusive.
- Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
- Subject is able to fast for 14 hours and consume standard meals.
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (morphine \& cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
Key exclusion criteria (17 listed)
- Subjects who refused to sign Informed Consent Form.
- Inability to take oral medication.
- Pregnant and lactating females.
- History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
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 |
|---|---|---|
| DexlansoprazoleAlso: DelanzoTMDR 60 mg capsule, hardDexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm. | Drug | DelanzoTMDR group |
| DexlansoprazoleAlso: Dexilant® 60 mg capsule, hardDexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm. | Drug | Dexilant® Group |
Primary outcome
Cmax
Time frame: 24 hours
Determination of plasma drug concentration
Tmax
Time frame: 24 hours
Time to reach maximum plasma drug concentration
AUC
Time frame: 24 hours
Area under the Plasma concentration Versus time curve
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 29 Nov 2023.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will only be available upon reasonable request to PI, subject to the confidentiality of the participants.
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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.
Prof. Dr. Muhammad R Shah, PhD principal investigator
Center for bio-equivalence, and clinical research, university of karachi
Dr. Naghma Hashmi (Co-PI), PhD principal investigator
Center for bio-equivalence, and clinical research, university of karachi
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 Dexlansoprazole in people with Healthy and Bioequivalence Study, run by University of Karachi at 1 site in Pakistan.
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 11 inclusion and 17 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 29 Nov 2023. 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 Pakistan. 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?
Cmax (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.