Healthy VolunteersPhase 1NCT05025072
A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Hydroxycarbamide in Healthy Volunteers
A Phase 1 study testing Hydroxycarbamide dispersible tablets and Hydroxycarbamide film-coated tablet in people with Healthy Volunteers, run by Theravia at 1 site in United Kingdom.
Trial summary
This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and hydroxycarbamide film-coated tablet (1000 mg) (reference IMP)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hydroxycarbamide dispersible tablets and Hydroxycarbamide film-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2021to 29 Sep 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants, between 18 and 50 years of age, inclusive.
- Female participant of childbearing potential willing to use a highly effective method of contraception, if applicable from the first dose until 3 months after the last dose of IMP.
- Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation.
- Female participant with a negative pregnancy test at Screening.
- Male participant (and partner of child bearing potential) willing to use a highly method of contraception, if applicable from first dose until 3 months after last dose of IMP.
- Participant with a BMI of 18-29.9 kg/m2.
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- No clinically significant history of previous allergy / sensitivity to hydroxycarbamide or any of the excipients contained within the IMP(s).
- No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP.
- Participant with a negative urinary DOA screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP.
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead ECG determined within 28 days before the first dose of IMP.
- No clinically significant abnormalities in vital signs determined within 28 days before the first dose of IMP.
- Participant must be available to complete the study.
- Participant must satisfy an Investigator about his/her fitness to participate in the study.
- Participant must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives prior to the first dose of IMP.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
- A clinically significant history of drug or alcohol abuse within the past two years.
- Inability to communicate well with the Investigators.
- Participation in a New Chemical Entity clinical study within the previous 3 months or five half-lives whichever is the longest, or a marketed drug clinical study within the 30 days or five half-lives whichever is the longest, before the first dose of IMP.
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- Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- Users of nicotine products i.e., current smokers or ex-smokers who have smoked within 6 months prior to Screening or users of cigarette replacements
- Female participants who are pregnant, breastfeeding or lactating.
- Participants who have received any live or attenuated vaccine within 28 days of the first dose of IMP, or who are planning to receive a vaccine up to 28 days after receiving the last dose of IMP in Treatment Period 2.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and hydroxycarbamide film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty (30) healthy male and female participants, between 18 and 50 years of age are planned to participate in the study.
Study participants will be randomised to one of the 2 possible combination sequences. After each treatment administration, blood samples will be collected at specific time points to assess the Pharmacokinetics (PK) parameters.
- Conditions
- Healthy Volunteers
- Being tested
- Hydroxycarbamide dispersible tablets, Hydroxycarbamide film-coated tablet
- Keywords
- Hydroxycarbamide, Hydroxyurea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxycarbamide dispersible tabletsDrug
Hydroxycarbamide dispersible tablets (20 x 50 mg)
Hydroxycarbamide film-coated tabletDrug
Hydroxycarbamide film-coated tablet (1000 mg)
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Hydroxycarbamide dispersible tablets (20 x 50 mg) then Hydroxycarbamide film-coated tablet (1000 mg) Receives: Drug: Hydroxycarbamide dispersible tablets; Drug: Hydroxycarbamide film-coated tablet |
| Sequence B | Experimental | Hydroxycarbamide film-coated tablet (1000 mg) then Hydroxycarbamide dispersible tablets (20 x 50 mg) Receives: Drug: Hydroxycarbamide dispersible tablets; Drug: Hydroxycarbamide film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The observed maximum concentration (Cmax) in plasma
Measured: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
AUC0-infinity
The AUC from time 0 to infinity
Measured: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
AUC0-t
The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t)
Measured: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
Secondary outcomes (3)
Tmax
The time at which Cmax is apparent
Measured: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
t1/2
The terminal elimination half-life
Measured: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
Adverse Events
Number of participants with Adverse Events
Measured: Day-1, Day1, Day2 of each treatement period, and up to the end of study visit which occured 1 to 3 days post last IMP administration for a maximum duration of approximately 7 weeks per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start30 Jul 2021
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Oncodesign SA, PhinC Development
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, MD, Principal investigator, Simbec-Orion Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025072
- Sponsor's protocol ID
- SIK-FR-21-1
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Hydroxycarbamide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05025072
- Acronym / sponsor ID
- SIK-FR-21-1
- Conditions
- Healthy Volunteers
- Keywords
- Hydroxycarbamide, Hydroxyurea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TheraviaIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Oncodesign SA, PhinC Development
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and hydroxycarbamide film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty (30) healthy male and female participants, between 18 and 50 years of age are planned to participate in the study.
Study participants will be randomised to one of the 2 possible combination sequences. After each treatment administration, blood samples will be collected at specific time points to assess the Pharmacokinetics (PK) parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Hydroxycarbamide dispersible tablets, Drug: Hydroxycarbamide film-coated tabletHydroxycarbamide dispersible tablets (20 x 50 mg) then Hydroxycarbamide film-coated tablet (1000 mg) |
| Sequence B | Experimental | Drug: Hydroxycarbamide dispersible tablets, Drug: Hydroxycarbamide film-coated tabletHydroxycarbamide film-coated tablet (1000 mg) then Hydroxycarbamide dispersible tablets (20 x 50 mg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy male and female participants, between 18 and 50 years of age, inclusive.
- Female participant of childbearing potential willing to use a highly effective method of contraception, if applicable from the first dose until 3 months after the last dose of IMP.
- Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation.
- Female participant with a negative pregnancy test at Screening.
- Male participant (and partner of child bearing potential) willing to use a highly method of contraception, if applicable from first dose until 3 months after last dose of IMP.
Key exclusion criteria (10 listed)
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives prior to the first dose of IMP.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
- A clinically significant history of drug or alcohol abuse within the past two years.
- Inability to communicate well with the Investigators.
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 |
|---|---|---|
| Hydroxycarbamide dispersible tabletsHydroxycarbamide dispersible tablets (20 x 50 mg) | Drug | Sequence A, Sequence B |
| Hydroxycarbamide film-coated tabletHydroxycarbamide film-coated tablet (1000 mg) | Drug | Sequence A, Sequence B |
Primary outcome
Cmax
Time frame: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
The observed maximum concentration (Cmax) in plasma
AUC0-infinity
Time frame: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
The AUC from time 0 to infinity
AUC0-t
Time frame: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t)
3 secondary outcomes
Tmax
Time frame: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
t1/2
Time frame: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose
Adverse Events
Time frame: Day-1, Day1, Day2 of each treatement period, and up to the end of study visit which occured 1 to 3 days post last IMP administration for a maximum duration of approximately 7 weeks per participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Annelize Koch, MD principal investigator
Simbec-Orion Group
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 Hydroxycarbamide dispersible tablets and Hydroxycarbamide film-coated tablet in people with Healthy Volunteers, run by Theravia at 1 site in United Kingdom.
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 15 inclusion and 10 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 Sep 2026. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Day 1: prior to dose, 10 mins, 15 mins, 30 mins, 45 mins, 1 hr, 1 hr 30 mins, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr post-Day 1 dose Day 2: 24 hr post-Day 1 dose). 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 Sep 2026.