Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

Orphelia Pharma

Status and phase: Completed; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: Ped-TMZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT04467346

ORP-TMZ-I-a

Details and patient eligibility

About

Primary objective:

• Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration.

Secondary objectives:

• Define the pharmacokinetic parameters of Temozolomide Oral Suspension.
• Assess the buccal safety of Temozolomide Oral Suspension.

Full description

The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly diagnosed glioblastoma multiforme treated with temozolomide (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma treated with temozolomide as monotherapy (200mg/m2).
• Male and female patients at least 18 of age.
• Non-pregnant, non-breast feeding female.
• Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².
• Having given a written informed consent

Exclusion criteria

• Co-administration of sodium valproate
• Patients with (naso)gastric tubes
• Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Ped-TMZ

Experimental group

Description:

Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition.

Treatment:

Drug: Ped-TMZ

Temodal capsule

Active Comparator group

Description:

Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. The administration will take place around 8:00 a.m. followed with 240 mL of tap water, in sitting position and under fasting condition

Treatment:

Drug: Ped-TMZ