HealthyPhase 1NCT01511757
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
A Phase 1 study testing Fluconazole in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2002to Jul 2002
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History or presence of significant:
- cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.
- Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.
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- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days, or
- 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
- 1000 mL of blood in 90 days,
- 1250 mL of blood in 120 days,
- 1500 mL of blood in 180 days,
- 2000 mL of blood in 270 days,
- 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
Canada1 site
MDS Pharma Services
Cohen Street, Saint-laurent, Montreal (quebec), H4R 2N6
About this study
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.
Read the detailed description
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.
- Conditions
- Healthy
- Being tested
- Fluconazole
- Keywords
- Bioequivalence, Fluconazole, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Also called Dr. Reddy's Laboratories
Fluconazole Tablets, 200 mg
FluconazoleDrug
Also called Diflucan (Pfizer)
fluconazole 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited. Receives: Drug: Fluconazole |
| Diflucan | Active comparator | Diflucan 200 mg fluconazole tablets of Pfizer Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJun 2002
- Primary completionJun 2002
- Study completionJul 2002
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaetano Morelli, MD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511757
- Sponsor's protocol ID
- AA01514
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.
- ClinicalTrials.gov ID
- NCT01511757
- Acronym / sponsor ID
- AA01514
- Conditions
- Healthy
- Keywords
- Bioequivalence, Fluconazole, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 19 Jan 2012 (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.
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.
Detailed description
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: FluconazoleFluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited. |
| Diflucan | Active comparator | Drug: FluconazoleDiflucan 200 mg fluconazole tablets of Pfizer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.
- Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.
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 |
|---|---|---|
| FluconazoleAlso: Dr. Reddy's LaboratoriesFluconazole Tablets, 200 mg | Drug | Fluconazole |
| FluconazoleAlso: Diflucan (Pfizer)fluconazole 200 mg | Drug | Diflucan |
Primary outcome
Area Under Curve (AUC)
Time frame: pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.
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 19 Jan 2012.
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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.
Gaetano Morelli, MD principal investigator
MDS Pharma Services
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 Fluconazole in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
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 0 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 19 Jan 2012. 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 Canada. 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?
Area Under Curve (AUC) (time frame: pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.). 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 19 Jan 2012.