A Phase 1 interventional study of Hydroxycarbamide dispersible tablets and Hydroxycarbamide film-coated tablet in Healthy Volunteers, sponsored by Theravia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Theravia (part of Norgine) · Phase 1, Interventional, and Other
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.
Theravia is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Theravia became part of Norgine.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydroxycarbamide dispersible tablets (20 x 50 mg) then Hydroxycarbamide film-coated tablet (1000 mg)
Drug: Hydroxycarbamide dispersible tablets · Drug: Hydroxycarbamide film-coated tablet
Hydroxycarbamide film-coated tablet (1000 mg) then Hydroxycarbamide dispersible tablets (20 x 50 mg)
Drug: Hydroxycarbamide dispersible tablets · Drug: Hydroxycarbamide film-coated tablet
Hydroxycarbamide dispersible tablets (20 x 50 mg)
Hydroxycarbamide film-coated tablet (1000 mg)
Cmax
The observed maximum concentration (Cmax) in plasma
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
AUC0-infinity
The AUC from time 0 to 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
AUC0-t
The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (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
Tmax
The time at which Cmax is apparent
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
The terminal elimination half-life
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
Number of participants with 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.
| Milestone | Hydroxycarbamide Dispersible Tablets Then Hydroxycarbamide Film-coated Tablet | Hydroxycarbamide Film-coated Tablet Then Hydroxycarbamide Dispersible Tablets |
|---|---|---|
| Started | 13 | 15 |
| Completed | 13 | 15 |
| Not completed | 0 | 0 |
The observed maximum concentration (Cmax) in plasma
| µg/mL | Test IMP | Reference IMP |
|---|---|---|
| Cmax | 32.5 ± 32.0 | 31.0 ± 29.3 |
The AUC from time 0 to infinity
| h*µg/mL | Test IMP | Reference IMP |
|---|---|---|
| AUC0-infinity | 106.09 ± 18.7 | 105.92 ± 17.3 |
The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t)
| h*µg/mL | Test IMP | Reference IMP |
|---|---|---|
| AUC0-t | 102.04 ± 19.9 | 101.88 ± 18.2 |
The time at which Cmax is apparent
| h | Test IMP | Reference IMP |
|---|---|---|
| Tmax | 0.50 ± 1.50 | 0.50 ± 2.00 |
The terminal elimination half-life
| h | Test IMP | Reference IMP |
|---|---|---|
| t1/2 | 3.19 ± 15.8 | 3.25 ± 17.6 |
Number of participants with Adverse Events
| Participants | Test IMP | Reference IMP |
|---|---|---|
| Adverse Events | 2 | 5 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test IMP | 0/28 (0%) | 0/28 (0%) | 2/28 (7.1%) |
| Reference IMP | 0/28 (0%) | 0/28 (0%) | 5/28 (17.9%) |
| Event | Test IMP | Reference IMP |
|---|---|---|
| HeadacheNervous system disorders | 0/28 | 2/28 |
| ConstipationGastrointestinal disorders | 1/28 | 0/28 |
| NauseaGeneral disorders | 1/28 | 1/28 |
| VomitingGastrointestinal disorders | 0/28 | 1/28 |
| Decreased appetiteMetabolism and nutrition disorders | 0/28 | 1/28 |
| Skin irritationSkin and subcutaneous tissue disorders | 0/28 | 1/28 |
| Age, Continuous(years) | Sequence A | Sequence B | Total |
|---|---|---|---|
| Mean | 34.1 ± 9.6 | 36.5 ± 6.3 | 35.4 ± 7.9 |
| Sex: Female, Male(Participants) | Sequence A | Sequence B | Total |
|---|---|---|---|
| Female | 4 | 9 | 13 |
| Male | 9 | 6 | 15 |
| Race (NIH/OMB)(Participants) | Sequence A | Sequence B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 13 | 25 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sequence A | Sequence B | Total |
|---|---|---|---|
| United Kingdom | 13 | 15 | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hydroxyurea